Subfertility, FemalePhase 1/2NCT03881904
OCP Pretreatment in PCOS Patients Undergoing ICSI Using Antagonist Protocol
A Phase 1/2 study testing 0.075mg gestodene/0.03mg ethinylestradiol in people with Subfertility, Female, run by Ain Shams University at 1 site in Egypt.
Trial summary
373 women with PCOS undergoing a trial of IVF/ICSI will receive OCP from day 2 of the preceding cycle for 21 days followed by GnRH antagonist COH. Another 373 women with PCOS undergoing a trial of IVF/ICSI will start GnRH antagonist COH directly without OCP pretreatment. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Subfertility, Female
- What is being tested?
- 0.075mg gestodene/0.03mg ethinylestradiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 740 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 1 Jul 2019
- Phase
- Phase 1/2
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-39 years of age.
- BMI 18-29 Kg/m2
- Polycystic ovary syndrome, diagnosed - according to the revised 2003 consensus on diagnostic criteria of polycystic ovary syndrome by the Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group - by the presence of two of the following three diagnostic features:
- Oligo- or anovulation [defined as fewer than eight episodes of menstrual bleeding per year or menses that occur at intervals greater than 35 days].
- Clinical hyperandrogenism [defined by the presence of hirsutism (assessed by a modified Ferriman-Gallwey score ≥ 8), acne or androgenic alopecia] and/or biochemical signs of hyperandrogenism [defined by elevated free androgen index]
- Polycystic ovaries [defined as presence of 12 or more follicles in each ovary measuring 2 - 9 mm in diameter, and/or increased ovarian volume > 10 mL) in the early follicular phase (cycle days 3 - 5) in regularly menstruating women. Oligo-/amenorrhoeic women should be scanned either at random or between days 3 and 5 after a progestin-induced withdrawal bleeding. This definition does not apply to women taking oral contraceptive pills, since their use modifies ovarian morphology in normal women and putatively in women with PCO.
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- After exclusion of other etiologies (congenital adrenal hyperplasia, androgen secreting tumors, Cushing's syndrome, hypothyroidism and hyperprolactinemia).
- Normal transvaginal ultrasonography apart from polycystic ovaries (see before).
- Normal office hysteroscopy.
- Normal hysterosalpingography.
- Absence of any structural pathological findings in laparoscopy apart from enlarged sclerotic polycystic ovaries.
- Normal hormonal profile (apart from hormonal abnormalities associated with PCOS), e.g. normal thyroid function tests
- Normal parameters of male semen analysis according to WHO criteria 2010.
- First trial IVF/ICSI.
- Written and signed informed consent by the patient to participate in the study.
Who cannot join
- Age more than 39 years.
- BMI more than 29 Kg/m2
- Abnormal ultrasonographic finding, e.g. endometrial polyps, fibroids or ovarian cysts.
- Abnormal hysteroscopic finding, e.g. endometrial polyps, endometrial hyperplasia or fibroid.
- Abnormal hysterosalpingographic finding, e.g. hydrosalpinx or peritoneal adhesions.
- Abnormal male or female karyotyping.
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- Abnormal endocrinological profile during ovarian stimulation not attributed to PCOS, e.g. hypothyroidism, FSH > 12 mIU/mL on day 3.
- Previous trials of IVF/ICSI.
- Positive anticardiolipin antibodies or lupus anticoagulant.
- Positive thrombophilia screen.
- Abnormal semen analysis parameters according to WHO criteria 2010.
- Any hormonal treatment within the last 3 months.
- Any treatment for insulin resistance within the last 3 months, e.g. metformin or leptin.
- Any chronic medical disorder, e.g. hypertension, autoimmune disorders, … etc.
- Any category 4 medical condition that contraindicates the usage of OCP according to the WHO Medical eligibility criteria, 2015:
- Smoking with age ≥ 35 years and cigarettes ≥ 15 /day.
- Hypertension (systolic ≥ 160 mmHg or diastolic ≥ 90 mmHg).
- Hypertension with vascular disease.
- Previous history or acute DVT/PE.
- Any known thrombogenic mutations.
- Complicated valvular heart disease.
- Systemic lupus erythematosus with positive or unkown antiphospholipid antibodies.
- Migraine with aura.
- Diabetes with nephropathy/neuropathy/retinopathy.
- Diabetes > 20 years.
- Acute hepatitis, severe cirrhosis or liver tumors.
- Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AinShams Maternity Hospital
Cairo, 002
Khaled Afifi, MSc, 01009981222, DrKhaledAfifi@hotmail.com
About this study
Official title: Oral Contraceptive Pill Pretreatment in Polycystic Ovary Syndrome Patients Undergoing IVF/ICSI Using the Gonadotrophin Releasing Hormone Antagonist Protocol (A Randomized Controlled Trial)
373 women with PCOS undergoing a trial of IVF/ICSI will receive OCP from day 2 of the preceding cycle for 21 days followed by GnRH antagonist COH.
Another 373 women with PCOS undergoing a trial of IVF/ICSI will start GnRH antagonist COH directly without OCP pretreatment.
Both groups will be followed up for effect on ongoing pregnancy rate.
Read the detailed description
The study will include 740 women with polycystic ovary syndrome undergoing IVF/ICSI cycle using flexible antagonist protocol.
Randomization:
Patients fulfilling the inclusion criteria will be randomized to two groups.
Study Group:
This group will include 373 women with PCOS undergoing a trial of IVF/ICSI. This group will receive OCP from day 2 of the preceding cycle for 21 days followed by GnRH antagonist COH.
Control Group:
This group will include 373 women with PCOS undergoing a trial of IVF/ICSI. This group will start GnRH antagonist COH directly without OCP pretreatment.
Random allocation sequence generation:
A computer generated list via MedCalc ® Software, version 13.2.2 will be used, assigning each participant number to either study groups.
Allocation Concealment:
Assignment will be done by sequentially numbered, otherwise identical, sealed envelopes (SNOSE), each containing a 2-inch by 2-inch paper with a written code designating the assigned group. These papers will be placed in a folded sheet of aluminum foil fitted inside the envelope. Effort will be taken to assure absence of any detectable differences in size or weight between intervention and control envelopes. Envelopes will be chosen to be opaque and lined inside with carbon paper. Envelopes will be opened sequentially only after writing the subject's tracking information on the envelope so that the carbon paper served as an audit trail.
IVF/ICSI cycle will be done using flexible anatgonist protocol in both groups.
Primary outcome will be ongoing pregnancy rate.
Secondary outcomes will be biochemical and clinical pregnancy rates.
- Conditions
- Subfertility, Female
- Being tested
- 0.075mg gestodene/0.03mg ethinylestradiol
- Keywords
- PCOS, Anatgonist protocol, OCP pretreatment
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.075mg gestodene/0.03mg ethinylestradiolDrug
Also called Gynera®
OCPs will be started from day 2 of the cycle preceding COH and continued for 21 days, then induction of ovulation using antagonist protocol will be started.
| Study group | Role | What they receive |
|---|---|---|
| OCP Group | Active comparator | This group will include 373 women with PCOS undergoing a trial of IVF/ICSI. This group will receive 0.075mg gestodene/0.03mg ethinylestradiol (Gynera®, Bayer Schering Pharma AG, Germany) from day 2 of the preceding cycle for 21 days followed by GnRH antagonist COH. Receives: Drug: 0.075mg gestodene/0.03mg ethinylestradiol |
| Control Group | No intervention | This group will include 373 women with PCOS undergoing a trial of IVF/ICSI. This group will start GnRH antagonist COH directly without OCP pretreatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Number of pregnancies completing ≥20 weeks gestational age expressed per 100 embryo transfer cycles
Measured: 20 gestational weeks
Secondary outcomes (3)
Chemical pregnancy rate
Number of biochemical pregnancies (evidenced by positive pregnancy test in serum or urine without ultrasound evidence of a gestational sac) expressed per 100 embryo transfer cycles
Measured: 6 gestational weeks
Clinical pregnancy rate
Number of clinical pregnancies (evidenced by ultrasound visualization of a gestational sac and embryonic pole with heartbeat) expressed per 100 embryo transfer cycles
Measured: 6 gestational weeks
Live birth rate
The number of deliveries (> 28 weeks GA) that resulted in a live born neonate, expressed per 100 embryo transfers
Measured: 38 gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Jun 2017
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subfertility, FemaleStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Afifi, Ain Shams University
- Investigators
- Mostafa Fouad, MD, Principal investigator, Assistant ProfessorAhmed Abbas, MD, Study director, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881904
- Sponsor's protocol ID
- OCP-AntagonistPCOS
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2019
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Contraceptive Pill Pretreatment in Polycystic Ovary Syndrome Patients Undergoing IVF/ICSI Using the Gonadotrophin Releasing Hormone Antagonist Protocol (A Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT03881904
- Acronym / sponsor ID
- OCP-AntagonistPCOS
- Conditions
- Subfertility, Female
- Keywords
- PCOS, Anatgonist protocol, OCP pretreatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 740 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 20 Mar 2019 (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.
373 women with PCOS undergoing a trial of IVF/ICSI will receive OCP from day 2 of the preceding cycle for 21 days followed by GnRH antagonist COH.
Another 373 women with PCOS undergoing a trial of IVF/ICSI will start GnRH antagonist COH directly without OCP pretreatment.
Both groups will be followed up for effect on ongoing pregnancy rate.
Detailed description
The study will include 740 women with polycystic ovary syndrome undergoing IVF/ICSI cycle using flexible antagonist protocol.
Randomization:
Patients fulfilling the inclusion criteria will be randomized to two groups.
Study Group:
This group will include 373 women with PCOS undergoing a trial of IVF/ICSI. This group will receive OCP from day 2 of the preceding cycle for 21 days followed by GnRH antagonist COH.
Control Group:
This group will include 373 women with PCOS undergoing a trial of IVF/ICSI. This group will start GnRH antagonist COH directly without OCP pretreatment.
Random allocation sequence generation:
A computer generated list via MedCalc ® Software, version 13.2.2 will be used, assigning each participant number to either study groups.
Allocation Concealment:
Assignment will be done by sequentially numbered, otherwise identical, sealed envelopes (SNOSE), each containing a 2-inch by 2-inch paper with a written code designating the assigned group. These papers will be placed in a folded sheet of aluminum foil fitted inside the envelope. Effort will be taken to assure absence of any detectable differences in size or weight between intervention and control envelopes. Envelopes will be chosen to be opaque and lined inside with carbon paper. Envelopes will be opened sequentially only after writing the subject's tracking information on the envelope so that the carbon paper served as an audit trail.
IVF/ICSI cycle will be done using flexible anatgonist protocol in both groups.
Primary outcome will be ongoing pregnancy rate.
Secondary outcomes will be biochemical and clinical pregnancy rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCP Group | Active comparator | Drug: 0.075mg gestodene/0.03mg ethinylestradiolThis group will include 373 women with PCOS undergoing a trial of IVF/ICSI. This group will receive 0.075mg gestodene/0.03mg ethinylestradiol (Gynera®, Bayer Schering Pharma AG, Germany) from day 2 of the preceding cycle for 21 days followed by GnRH antagonist COH. |
| Control Group | No intervention | –This group will include 373 women with PCOS undergoing a trial of IVF/ICSI. This group will start GnRH antagonist COH directly without OCP pretreatment. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Age 18-39 years of age.
- BMI 18-29 Kg/m2
- Polycystic ovary syndrome, diagnosed - according to the revised 2003 consensus on diagnostic criteria of polycystic ovary syndrome by the Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group - by the presence of two of the following three diagnostic features:
- After exclusion of other etiologies (congenital adrenal hyperplasia, androgen secreting tumors, Cushing's syndrome, hypothyroidism and hyperprolactinemia).
- Normal transvaginal ultrasonography apart from polycystic ovaries (see before).
Key exclusion criteria (27 listed)
- Age more than 39 years.
- BMI more than 29 Kg/m2
- Abnormal ultrasonographic finding, e.g. endometrial polyps, fibroids or ovarian cysts.
- Abnormal hysteroscopic finding, e.g. endometrial polyps, endometrial hyperplasia or fibroid.
- Abnormal hysterosalpingographic finding, e.g. hydrosalpinx or peritoneal adhesions.
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 |
|---|---|---|
| 0.075mg gestodene/0.03mg ethinylestradiolAlso: Gynera®OCPs will be started from day 2 of the cycle preceding COH and continued for 21 days, then induction of ovulation using antagonist protocol will be started. | Drug | OCP Group |
Primary outcome
Ongoing pregnancy rate
Time frame: 20 gestational weeks
Number of pregnancies completing ≥20 weeks gestational age expressed per 100 embryo transfer cycles
3 secondary outcomes
Chemical pregnancy rate
Time frame: 6 gestational weeks
Clinical pregnancy rate
Time frame: 6 gestational weeks
Live birth rate
Time frame: 38 gestational weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- 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.
Mostafa Fouad, MD principal investigator
Assistant Professor
Ahmed Abbas, MD study director
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 0.075mg gestodene/0.03mg ethinylestradiol in people with Subfertility, Female, run by Ain Shams University at 1 site in Egypt.
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 15 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 20 Mar 2019. 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 Egypt. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khaled Afifi, MSc (01009981222, DrKhaledAfifi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: 20 gestational weeks). 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 20 Mar 2019.