Polycystic Ovarian SyndromePhase 2/3NCT04870502
Effect of Ubiquinol Supplementation on Ovulation Induction in Clomiphene Citrate Resistance
A Phase 2/3 study of Polycystic Ovarian Syndrome, run by Saudi German Hospital - Madinah at 1 site in Saudi Arabia.
Trial summary
Objective: To evaluate potential benefits of adding the active form of Coenzyme Q10 (Ubiquinol) to Clomiphene Citrate compared with Human Menopausal Gonadotropins (hMG) in Clomiphene Citrate resistant PCOS patients. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovarian Syndrome
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Apr 2019to 31 Jul 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with Clomiphene Citrate resistant PCOS who fulfilled the following inclusion criteria:
- Age 18 to 35 years
- Body mass index (BMI) between 18.5 and 34.9 kg/m2
- Presenting with primary or secondary infertility.
- PCOS was diagnosed according to the Rotterdam ESHRE/ASRM Consensus workshop, with at least 2 of the following 3 criteria:
- A- Oligo- and/or anovulation; manifested by oligomenorrhea or amenorrhea. Oligomenorrhea was defined as cycle interval of more than 35 days but less than six months. Amenorrhea was defined as absence of menstruation for six months or more.
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- B- Hyperandrogenism; biochemical and/or clinical in the form of acne or hirsutism defined as a score of 8 or higher using the modified Ferriman-Gallwey scoring system when abnormal hair distribution was assessed in nine body areas and given a score of 0 to 4.
- C - Polycystic ovarian morphology detected by transvaginal ultrasound with the presence of 12 or more follicles measuring 2-9 mm in diameter in one or both ovaries, and/or increased ovarian volume >10 mL.
- Clomiphene Citrate resistance was defined as failure of ovulation after administration of Clomiphene Citrate in a dose of 150 mg for 5 days per cycle, for two or three cycles.
- Patent both fallopian tubes and normal uterine cavity as evidenced by hysterosalpingography (HSG).
- Their partners had normal semen parameters as defined by the modified WHO 2010 criteria.
Who cannot join
- Morbidly obese patients with BMI ≥35 Kg/2m.
- Abnormal husband semen analysis.
- Abnormal HSG or laparoscopic evidence of pelvic adhesions.
- Patients receiving statin drugs for cholesterol, beta-blockers for high blood pressure, or tricyclic antidepressants, were also excluded as these drugs can lower the levels of ubiquinol in the body.
Trial locations and contacts
1 site in 1 country.
About this study
Objective: To evaluate potential benefits of adding the active form of Coenzyme Q10 (Ubiquinol) to Clomiphene Citrate compared with Human Menopausal Gonadotropins (hMG) in Clomiphene Citrate resistant PCOS patients.
Methods: 148 PCOS Patients with Clomiphene Citrate resistance were randomized into two groups (A and B). In group A, controlled ovarian stimulation was done by Clomiphene Citrate 150 mg daily (from 2nd till 6th day of cycle) together with Ubiquinol starting from 2nd day till day of hCG triggering in a dose of 100 mg orally once daily. In group B, hMG was given from 2nd day of the cycle in a dose ranging from 75 to 225 IU. Serial transvaginal ultrasonography was done starting on cycle day 8 and continued till size of leading follicle reaches 18 mm or more then ovulation triggering was done. Thereafter, patients were advised for a timed intercourse (TI) after 36 hours. A blood sample was withdrawn seven days after hCG triggering, for measurement of serum progesterone. If the Patient presented with a missed period for one week, a serum sample was sent for β-hCG.
Read the detailed description
Patients were divided randomly into two groups (A and B), who underwent controlled ovarian stimulation and timed intercourse, using random table computer software (Open Epi version 3.21).
Basal transvaginal ultrasonography (TVS) was done on day 2 of the cycle before commencing ovarian stimulation. For patients presenting with amenorrhea or oligomenorrhea, dydrogesterone 10 mg (Duphaston®; Abbott Biologicals B.V.) was prescribed (3 times daily for 10 days) to achieve withdrawal bleeding before starting induction of ovulation.
In group A, controlled ovarian stimulation (COS) was done by Clomiphene Citrate (Fertab® 50 mg tablets, Zynova. SITCO Pharma.) as 150 mg (3 tablets) daily for 5 days (from 2nd day till 6th day of the cycle) together with Ubiquinol (active form of Coenzyme Q10) starting from 2nd day till the day of human Chorionic Gonadotropin (hCG) triggering in a dose of 100 mg capsules orally once daily, immediately after meal (Nutraquinol®; Jamjoom Pharma Nutraceuticals). In group B, Human Menopausal Gonadotropins (hMG) (Merional® 75 I.U. vials, IBSA.) IM was given from 2nd day of the cycle in a dose ranging from 75 to 225 IU according to the patient's response. Patients were instructed not to take any non-study drugs during the whole study period. All patients did not receive any drug for induction of ovulation 3 months prior to participation in the study.
Serial transvaginal ultrasonography was done for assessment of follicular growth (number and diameter of follicles) and endometrial thickness (measured on sagittal view of the uterus by including the whole endometrium at the point of its maximum thickness), starting on cycle day 8, using vaginal 4.5 MHz endocavity transducer (Esaote Mylab 50 Xvision Ultrasound, Italy), and was continued with an interval of 1-3 days till the size of the leading follicle reaches 18 mm or more in mean follicular diameter. Then ovulation triggering was done by an intramuscular single dose of human Chorionic Gonadotropin (Epifasi® 5000 IU vials, EIPICO, Egypt.) 2 vials (10,000 IU). Thereafter, patients were advised for a timed intercourse (TI) 36 hours after ovulation triggering.
All measurements were obtained by a blinded single operator. All data were digitally stored and were not analyzed till the end of the study.
Thereafter, patients were asked to come for follow up, 7 days after hCG triggering, where a blood sample (2 mL) was withdrawn for measurement of serum progesterone (ng/ml). Collected samples were centrifuged and then stored at 2-8 °C until enzyme immunoassay was done. If the Patient presented with a missed period for a week, a serum sample was sent for β-hCG using immunoassay.
Patients with positive serum pregnancy test, defined as β-hCG concentration >10 mU/ml, were examined by abdominal ultrasonography 6 weeks after the first day of their last menstrual period with 3.5 MHz sector transducer (Esaote Mylab 50 Xvision Ultrasound, Italy) to detect an intrauterine gestational sac (Clinical pregnancy). Patients who failed to get pregnant were requested for follow up for 2 more consecutive cycles with the same protocol.
The primary outcomes measured were; number of cases achieving follicular growth to the size of mature follicle ≥ 18 mm (1-3 follicles) during the three cycles of stimulation, number of stimulated cycles (till pregnancy occurs or completing the 3 cycles of the study, whichever is earlier), the endometrial thickness on the day of triggering, and the luteal function as assessed by mid-luteal serum progesterone measurements.
The secondary outcomes were; number of cases with positive serum pregnancy test and the clinical pregnancy rate among the two groups during the three cycles of treatment.
- Conditions
- Polycystic Ovarian Syndrome
- Being tested
- Controlled ovarian stimulation by Combined Clomiphene Citrate and Ubiquinol Versus hMG
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled ovarian stimulation by Combined Clomiphene Citrate and Ubiquinol Versus hMGDrug
Also called Fertab® 50 mg tablets, Zynova. SITCO Pharma., Nutraquinol®; Jamjoom Pharma Nutraceuticals, Merional® 75 I.U. vials, IBSA
In group A, controlled ovarian stimulation (COS) was done by Clomiphene Citrate (Fertab® 50 mg tablets, Zynova. SITCO Pharma.) as 150 mg (3 tablets) daily for 5 days (from 2nd day till 6th day of the cycle) together with Ubiquinol (active form of Coenzyme Q10) starting from 2nd day till the day of human Chorionic Gonadotropin (hCG) triggering in a dose of 100 mg capsules orally once daily, immediately after meal (Nutraquinol®; Jamjoom Pharma Nutraceuticals). In group B, Human Menopausal Gonadotropins (hMG) (Merional® 75 I.U. vials, IBSA.) IM was given from 2nd day of the cycle in a dose ranging from 75 to 225 IU according to the patient's response. Patients were instructed not to take any non-study drugs during the whole study period.
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene citrate and Ubiquinol | Active comparator | Controlled ovarian stimulation (COS) was done by Clomiphene Citrate (Fertab® 50 mg tablets, Zynova. SITCO Pharma.) as 150 mg (3 tablets) daily for 5 days (from 2nd day till 6th day of the cycle) together with Ubiquinol (active form of Coenzyme Q10) starting from 2nd day till the day of human Chorionic Gonadotropin (hCG) triggering in a dose of 100 mg capsules orally once daily, immediately after meal (Nutraquinol®; Jamjoom Pharma Nutraceuticals). Receives: Drug: Controlled ovarian stimulation by Combined Clomiphene Citrate and Ubiquinol Versus hMG |
| Human Menopausal Gonadotropins (hMG) | Active comparator | Controlled ovarian stimulation (COS) was done by Human Menopausal Gonadotropins (hMG) (Merional® 75 I.U. vials, IBSA.) IM was given from 2nd day of the cycle in a dose ranging from 75 to 225 IU according to the patient's response. Receives: Drug: Controlled ovarian stimulation by Combined Clomiphene Citrate and Ubiquinol Versus hMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the number of cases achieving follicular growth to the size of mature follicle ≥ 18 mm (1-3 follicles) during the three cycles of stimulation
Serial transvaginal ultrasonography was done for assessment of follicular growth (number and diameter of follicles) starting on 8th day of the menstrual cycle, using vaginal 4.5 MHz endocavity transducer (Esaote Mylab 50 Xvision Ultrasound, Italy), and is continued with an interval of 1-3 days till the size of the leading follicle reaches 18 mm or more in the mean follicular diameter. The mean follicular diameter (MFD) is calculated by summation of the length and width of the growing follicle, divided by two. Mature follicle is defined as a follicle with mean diameter of 18-22 mm. The estimated period of time is 3 menstrual cycles with each menstrual cycle ranging from 3-5 weeks in duration (a total of 9-15 weeks) or till pregnancy occurs whichever came first.
Measured: The estimated period of time is 3 menstrual cycles with each menstrual cycle ranging from 3-5 weeks in duration (a total of 9-15 weeks) or till pregnancy occurs whichever came first.
Change of the number of stimulated cycles (till pregnancy occurs or completing the 3 cycles of the study, whichever is earlier).
Controlled ovarian stimulation is carried out for 3 menstrual cycles. Each menstrual cycle is of 3-5 weeks duration. The estimated period of time is 3 menstrual cycles (total of 9-15 weeks) or till pregnancy occurs whichever came first.
Measured: The estimated period of time is 3 menstrual cycles with each menstrual cycle ranging from 3-5 weeks in duration (a total of 9-15 weeks) or till pregnancy occurs whichever came first.
Change of Luteal function as assessed by mid-luteal serum progesterone measurements.
Patients were asked to come for follow up, 7 days after hCG triggering, where a blood sample (2 mL) was withdrawn for measurement of serum progesterone (ng/mL). Collected samples were centrifuged and then stored at 2-8 °C until enzyme immunoassay was done. Normal luteal function was defined as mid-luteal serum progesterone levels > 10 ng/mL. This is carried out for 3 menstrual cycles of controlled ovarian stimulation. Each menstrual cycle is of 3-5 weeks duration. The estimated period of time is 3 menstrual cycles (total of 9-15 weeks) or till pregnancy occurs whichever came first.
Measured: The estimated period of time is 3 menstrual cycles with each menstrual cycle ranging from 3-5 weeks in duration (a total of 9-15 weeks) or till pregnancy occurs whichever came first.
Change of Endometrial thickness (mm) on the day of hCG triggering
Transvaginal ultrasonography was done for assessment of endometrial thickness in mm (measured on sagittal view of the uterus by including the whole endometrium at the point of its maximum thickness) on the day of hCG triggering using vaginal 4.5 MHz endocavity transducer (Esaote Mylab 50 Xvision Ultrasound, Italy). This is carried out for 3 menstrual cycles of controlled ovarian stimulation. Each menstrual cycle is of 3-5 weeks duration. The estimated period of time is 3 menstrual cycles (total of 9-15 weeks) or till pregnancy occurs whichever came first.
Measured: The estimated period of time is 3 menstrual cycles with each menstrual cycle ranging from 3-5 weeks in duration (a total of 9-15 weeks) or till pregnancy occurs whichever came first.
Secondary outcomes (2)
Change of the number of cases with positive serum pregnancy test (Chemical pregnancy)
If the Patient presented with a missed period for a week, a serum sample was sent for β-hCG using immunoassay. Positive serum pregnancy test is defined as serum β-hCG concentration >10 mU/mL. The estimated period of time is 3 menstrual cycles (total of 9-15 weeks) or till pregnancy occurs whichever came first.
Measured: The estimated period of time is 3 menstrual cycles with each menstrual cycle ranging from 3-5 weeks in duration (a total of 9-15 weeks) or till pregnancy occurs whichever came first.
Change of Clinical pregnancy rate
Patients with positive serum pregnancy test, defined as serum β-hCG concentration >10 mU/ml, were examined by abdominal ultrasonography, 6 weeks after the first day of their last menstrual period (LMP), using 3.5 MHz sector transducer (Esaote Mylab 50 Xvision Ultrasound, Italy) to detect an intrauterine gestational sac (Clinical pregnancy). Patients who failed to get pregnant were requested for follow up for 2 more consecutive cycles with the same protocol.
The estimated period of time is 3 menstrual cycles (total of 9-15 weeks) or till pregnancy occurs whichever came first.
Measured: The estimated period of time is 3 menstrual cycles with each menstrual cycle ranging from 3-5 weeks in duration (a total of 9-15 weeks) or till pregnancy occurs whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Apr 2019
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saudi German Hospital - Madinah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Mohamed Magdi Ammar, Saudi German Hospital - Madinah
- Investigators
- Islam Mohamed Magdi Ammar, M.D., Principal investigator, Saudi German Hospital - Madinah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870502
- Sponsor's protocol ID
- SGHM-MAR2019-OBGYN
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ubiquinol Supplementation on Ovulation Induction in Clomiphene Citrate Resistance
- ClinicalTrials.gov ID
- NCT04870502
- Acronym / sponsor ID
- SGHM-MAR2019-OBGYN
- Conditions
- Polycystic Ovarian Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Saudi German Hospital - MadinahUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To evaluate potential benefits of adding the active form of Coenzyme Q10 (Ubiquinol) to Clomiphene Citrate compared with Human Menopausal Gonadotropins (hMG) in Clomiphene Citrate resistant PCOS patients.
Methods: 148 PCOS Patients with Clomiphene Citrate resistance were randomized into two groups (A and B). In group A, controlled ovarian stimulation was done by Clomiphene Citrate 150 mg daily (from 2nd till 6th day of cycle) together with Ubiquinol starting from 2nd day till day of hCG triggering in a dose of 100 mg orally once daily. In group B, hMG was given from 2nd day of the cycle in a dose ranging from 75 to 225 IU. Serial transvaginal ultrasonography was done starting on cycle day 8 and continued till size of leading follicle reaches 18 mm or more then ovulation triggering was done. Thereafter, patients were advised for a timed intercourse (TI) after 36 hours. A blood sample was withdrawn seven days after hCG triggering, for measurement of serum progesterone. If the Patient presented with a missed period for one week, a serum sample was sent for β-hCG.
Detailed description
Patients were divided randomly into two groups (A and B), who underwent controlled ovarian stimulation and timed intercourse, using random table computer software (Open Epi version 3.21).
Basal transvaginal ultrasonography (TVS) was done on day 2 of the cycle before commencing ovarian stimulation. For patients presenting with amenorrhea or oligomenorrhea, dydrogesterone 10 mg (Duphaston®; Abbott Biologicals B.V.) was prescribed (3 times daily for 10 days) to achieve withdrawal bleeding before starting induction of ovulation.
In group A, controlled ovarian stimulation (COS) was done by Clomiphene Citrate (Fertab® 50 mg tablets, Zynova. SITCO Pharma.) as 150 mg (3 tablets) daily for 5 days (from 2nd day till 6th day of the cycle) together with Ubiquinol (active form of Coenzyme Q10) starting from 2nd day till the day of human Chorionic Gonadotropin (hCG) triggering in a dose of 100 mg capsules orally once daily, immediately after meal (Nutraquinol®; Jamjoom Pharma Nutraceuticals). In group B, Human Menopausal Gonadotropins (hMG) (Merional® 75 I.U. vials, IBSA.) IM was given from 2nd day of the cycle in a dose ranging from 75 to 225 IU according to the patient's response. Patients were instructed not to take any non-study drugs during the whole study period. All patients did not receive any drug for induction of ovulation 3 months prior to participation in the study.
Serial transvaginal ultrasonography was done for assessment of follicular growth (number and diameter of follicles) and endometrial thickness (measured on sagittal view of the uterus by including the whole endometrium at the point of its maximum thickness), starting on cycle day 8, using vaginal 4.5 MHz endocavity transducer (Esaote Mylab 50 Xvision Ultrasound, Italy), and was continued with an interval of 1-3 days till the size of the leading follicle reaches 18 mm or more in mean follicular diameter. Then ovulation triggering was done by an intramuscular single dose of human Chorionic Gonadotropin (Epifasi® 5000 IU vials, EIPICO, Egypt.) 2 vials (10,000 IU). Thereafter, patients were advised for a timed intercourse (TI) 36 hours after ovulation triggering.
All measurements were obtained by a blinded single operator. All data were digitally stored and were not analyzed till the end of the study.
Thereafter, patients were asked to come for follow up, 7 days after hCG triggering, where a blood sample (2 mL) was withdrawn for measurement of serum progesterone (ng/ml). Collected samples were centrifuged and then stored at 2-8 °C until enzyme immunoassay was done. If the Patient presented with a missed period for a week, a serum sample was sent for β-hCG using immunoassay.
Patients with positive serum pregnancy test, defined as β-hCG concentration >10 mU/ml, were examined by abdominal ultrasonography 6 weeks after the first day of their last menstrual period with 3.5 MHz sector transducer (Esaote Mylab 50 Xvision Ultrasound, Italy) to detect an intrauterine gestational sac (Clinical pregnancy). Patients who failed to get pregnant were requested for follow up for 2 more consecutive cycles with the same protocol.
The primary outcomes measured were; number of cases achieving follicular growth to the size of mature follicle ≥ 18 mm (1-3 follicles) during the three cycles of stimulation, number of stimulated cycles (till pregnancy occurs or completing the 3 cycles of the study, whichever is earlier), the endometrial thickness on the day of triggering, and the luteal function as assessed by mid-luteal serum progesterone measurements.
The secondary outcomes were; number of cases with positive serum pregnancy test and the clinical pregnancy rate among the two groups during the three cycles of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clomiphene citrate and Ubiquinol | Active comparator | Drug: Controlled ovarian stimulation by Combined Clomiphene Citrate and Ubiquinol Versus hMGControlled ovarian stimulation (COS) was done by Clomiphene Citrate (Fertab® 50 mg tablets, Zynova. SITCO Pharma.) as 150 mg (3 tablets) daily for 5 days (from 2nd day till 6th day of the cycle) together with Ubiquinol (active form of Coenzyme Q10) starting from 2nd day till the day of human Chorionic Gonadotropin (hCG) triggering in a dose of 100 mg capsules orally once daily, immediately after meal (Nutraquinol®; Jamjoom Pharma Nutraceuticals). |
| Human Menopausal Gonadotropins (hMG) | Active comparator | Drug: Controlled ovarian stimulation by Combined Clomiphene Citrate and Ubiquinol Versus hMGControlled ovarian stimulation (COS) was done by Human Menopausal Gonadotropins (hMG) (Merional® 75 I.U. vials, IBSA.) IM was given from 2nd day of the cycle in a dose ranging from 75 to 225 IU according to the patient's response. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Patients with Clomiphene Citrate resistant PCOS who fulfilled the following inclusion criteria:
- Age 18 to 35 years
- Body mass index (BMI) between 18.5 and 34.9 kg/m2
- Presenting with primary or secondary infertility.
- PCOS was diagnosed according to the Rotterdam ESHRE/ASRM Consensus workshop, with at least 2 of the following 3 criteria:
Key exclusion criteria (4 listed)
- Morbidly obese patients with BMI ≥35 Kg/2m.
- Abnormal husband semen analysis.
- Abnormal HSG or laparoscopic evidence of pelvic adhesions.
- Patients receiving statin drugs for cholesterol, beta-blockers for high blood pressure, or tricyclic antidepressants, were also excluded as these drugs can lower the levels of ubiquinol in the body.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled ovarian stimulation by Combined Clomiphene Citrate and Ubiquinol Versus hMGAlso: Fertab® 50 mg tablets, Zynova. SITCO Pharma., Nutraquinol®; Jamjoom Pharma Nutraceuticals, Merional® 75 I.U. vials, IBSAIn group A, controlled ovarian stimulation (COS) was done by Clomiphene Citrate (Fertab® 50 mg tablets, Zynova. SITCO Pharma.) as 150 mg (3 tablets) daily for 5 days (from 2nd day till 6th day of the cycle) together with Ubiquinol (active form of Coenzyme Q10) starting from 2nd day till the day of human Chorionic Gonadotropin (hCG) triggering in a dose of 100 mg capsules orally once daily, immediately after meal (Nutraquinol®; Jamjoom Pharma Nutraceuticals). In group B, Human Menopausal Gonadotropins (hMG) (Merional® 75 I.U. vials, IBSA.) IM was given from 2nd day of the cycle in a dose ranging from 75 to 225 IU according to the patient's response. Patients were instructed not to take any non-study drugs during the whole study period. | Drug | Clomiphene citrate and Ubiquinol, Human Menopausal Gonadotropins (hMG) |
Primary outcome
Change of the number of cases achieving follicular growth to the size of mature follicle ≥ 18 mm (1-3 follicles) during the three cycles of stimulation
Time frame: The estimated period of time is 3 menstrual cycles with each menstrual cycle ranging from 3-5 weeks in duration (a total of 9-15 weeks) or till pregnancy occurs whichever came first.
Serial transvaginal ultrasonography was done for assessment of follicular growth (number and diameter of follicles) starting on 8th day of the menstrual cycle, using vaginal 4.5 MHz endocavity transducer (Esaote Mylab 50 Xvision Ultrasound, Italy), and is continued with an interval of 1-3 days till the size of the leading follicle reaches 18 mm or more in the mean follicular diameter. The mean follicular diameter (MFD) is calculated by summation of the length and width of the growing follicle, divided by two. Mature follicle is defined as a follicle with mean diameter of 18-22 mm. The estimated period of time is 3 menstrual cycles with each menstrual cycle ranging from 3-5 weeks in duration (a total of 9-15 weeks) or till pregnancy occurs whichever came first.
Change of the number of stimulated cycles (till pregnancy occurs or completing the 3 cycles of the study, whichever is earlier).
Time frame: The estimated period of time is 3 menstrual cycles with each menstrual cycle ranging from 3-5 weeks in duration (a total of 9-15 weeks) or till pregnancy occurs whichever came first.
Controlled ovarian stimulation is carried out for 3 menstrual cycles. Each menstrual cycle is of 3-5 weeks duration. The estimated period of time is 3 menstrual cycles (total of 9-15 weeks) or till pregnancy occurs whichever came first.
Change of Luteal function as assessed by mid-luteal serum progesterone measurements.
Time frame: The estimated period of time is 3 menstrual cycles with each menstrual cycle ranging from 3-5 weeks in duration (a total of 9-15 weeks) or till pregnancy occurs whichever came first.
Patients were asked to come for follow up, 7 days after hCG triggering, where a blood sample (2 mL) was withdrawn for measurement of serum progesterone (ng/mL). Collected samples were centrifuged and then stored at 2-8 °C until enzyme immunoassay was done. Normal luteal function was defined as mid-luteal serum progesterone levels > 10 ng/mL. This is carried out for 3 menstrual cycles of controlled ovarian stimulation. Each menstrual cycle is of 3-5 weeks duration. The estimated period of time is 3 menstrual cycles (total of 9-15 weeks) or till pregnancy occurs whichever came first.
Change of Endometrial thickness (mm) on the day of hCG triggering
Time frame: The estimated period of time is 3 menstrual cycles with each menstrual cycle ranging from 3-5 weeks in duration (a total of 9-15 weeks) or till pregnancy occurs whichever came first.
Transvaginal ultrasonography was done for assessment of endometrial thickness in mm (measured on sagittal view of the uterus by including the whole endometrium at the point of its maximum thickness) on the day of hCG triggering using vaginal 4.5 MHz endocavity transducer (Esaote Mylab 50 Xvision Ultrasound, Italy). This is carried out for 3 menstrual cycles of controlled ovarian stimulation. Each menstrual cycle is of 3-5 weeks duration. The estimated period of time is 3 menstrual cycles (total of 9-15 weeks) or till pregnancy occurs whichever came first.
2 secondary outcomes
Change of the number of cases with positive serum pregnancy test (Chemical pregnancy)
Time frame: The estimated period of time is 3 menstrual cycles with each menstrual cycle ranging from 3-5 weeks in duration (a total of 9-15 weeks) or till pregnancy occurs whichever came first.
Change of Clinical pregnancy rate
Time frame: The estimated period of time is 3 menstrual cycles with each menstrual cycle ranging from 3-5 weeks in duration (a total of 9-15 weeks) or till pregnancy occurs whichever came first.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Islam Mohamed Magdi Ammar, M.D. principal investigator
Saudi German Hospital - Madinah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study of Polycystic Ovarian Syndrome, run by Saudi German Hospital - Madinah at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the number of cases achieving follicular growth to the size of mature follicle ≥ 18 mm (1-3 follicles) during the three cycles of stimulation (time frame: The estimated period of time is 3 menstrual cycles with each menstrual cycle ranging from 3-5 weeks in duration (a total of 9-15 weeks) or till pregnancy occurs whichever came first.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.