Polycystic Ovary SyndromeNCT03481582
Effect of Nitric Oxide Donors on Uterine and Subendometrial Blood Flow in Patients With Unexplained Infertility
A study testing Nitroglycerin and Three dimensional power doppler in people with Polycystic Ovary Syndrome and Infertility, Female, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of the study to evaluate effect of nitroglycerin trans-dermal patches on uterine and sub-endometrial blood flow in women with unexplained infertility. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Infertility, Female
- What is being tested?
- Nitroglycerin and Three dimensional power doppler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to 1 Mar 2018
- Phase
- Interventional
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20-35 years.6
- Normal husband's semen analysis (WHO 2010 Criteria):
- Count ≥15 million
- Motility ≥ 32% progressive motility
- Morphology ≥ 4% normal morphology
- Documented ovulation ( basal body temperature , mid-luteal serum progesterone ≥3 ng / ml and ultrasound monitoring of ovulation).
- Patent Fallopian tube and excluding uterine anomalies either by hystero-salpingogram (HSG) and/or laparoscopy.
- Normal hormonal profile (serum progesterone, E2, F.S.H, LH and T.S.H In the 2ND Day of menstrual cycle)
Who cannot join
- Male factor of infertility.
- Patients with uterine pathology as fibroids.
- Tubal factor of infertility diagnosed by hysterosalpingography (HSG) or laparoscopy.
- Patients with any contraindications for NO such as chronic liver and renal disease, known cardiac disease and migraine.
- Diagnosis of PCO based on Rotterdam criteria, two out of three of the following are required to make the diagnosis (Rotterdam, 2004):
- Oligo- and/or anovulation.
Show all 14Show fewer
- Clinical and/or biochemical signs of hyperandrogenism.
- Polycystic ovaries (by transvaginal ultrasound): the morphology of PCO has been defined as an ovary with 12 or more follicles measuring 2-9 mm in diameter and/or increased ovarian volume (>10 cm3) (Balen et al, 2003).
- Conditions that mimic PCOS; disorders that cause oligo/anovulation and/or hyperandrogenism, such as:
- Thyroid disease.
- Non classic congenital adrenal hyperplasia.
- Hyperprolactinemia.
- Androgen-secreting tumors.
- Women who had any medical comorbidity (e.g. autoimmune disease or diabetes mellitus) and those who have been using medications to induce ovulation or medications known to affect the VEGF concentration (NSAIDs) were not included in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of obstetrics and gynaecology, faculty of medicine, Ain shams university
Cairo, 11591
About this study
The purpose of the study to evaluate effect of nitroglycerin trans-dermal patches on uterine and sub-endometrial blood flow in women with unexplained infertility.
Read the detailed description
90 female patients will be divided into 2 equal groups:
- Group I: 30 female patients with unexplained infertility.
- Group II: 30 female patients with unexplained infertility will receive nitroglycerin trans-dermal patch.
All subjects will be subjected to the following:
- Proper history taking on past medical history, menstrual history and infertility workup.
- Proper examination (general, abdominal and local examinations)
- Investigations to diagnose unexplained infertility ( male partner's semen analysis as well as documented ovulation and a patent uterine cavity and Fallopian tubes in the female partner).
- Group II (30 patients with unexplained infertility)will receive: (nitrodermal®) 5 mg (patch)as a source of Nitric oxide from 2nd day of cycle till maturation of the follicles ≥ 18 mm just for one cycle
- All women included in each group will be subjected to trans-vaginal ultrasound for folliculometry till maturation of the follicle ≥18mm.
- Once the follicle reached ≥18 mm 3D power Doppler will be used to assess the uterine and sub-endometrial blood flow.
- All women in each group will be subjected to urinary luteinizing hormone (LH) assay. The urinary LH assay will be started on cycle day 11, and repeated daily till detection of the LH surge.
- Six days after detection of the LH surge, 3D power Doppler will be repeated to assess the uterine and sub-endometrial blood flow.
- Conditions
- Polycystic Ovary Syndrome, Infertility, Female
- Being tested
- Nitroglycerin, Three dimensional power doppler
- Keywords
- Nitroglycerin Trans-dermal Patch
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitroglycerinDrug
Also called nitrodermal patch
(nitrodermal®) 5 mg (patch)as a source of Nitric oxide from 2nd day of cycle till maturation of the follicles ≥ 18 mm just for one cycle.
Three dimensional power dopplerDevice
Once the follicle reached ≥18 mm 3D power Doppler will be used to assess the uterine and subendometrial blood flow
| Study group | Role | What they receive |
|---|---|---|
| Group without nitroglycerin | Active comparator | They will be subjected to TV ultrasound for folliculometry till maturation of the follicle ≥18mm then Three dimensional power Doppler will be used to assess the uterine and sub-endometrial blood flow. Receives: Device: Three dimensional power doppler |
| Group with nitroglycerin | Experimental | They will receive (nitrodermal®) 5 mg (patch) from 2nd day of cycle till maturation of the follicles ≥ 18 mm then Three dimensional power Doppler will be used to assess the uterine and sub-endometrial blood flow. Receives: Drug: Nitroglycerin; Device: Three dimensional power doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three dimensional power Doppler
Once the follicle reached ≥18 mm 3D power Doppler will be used to assess the uterine and sub-endometrial blood flow
Measured: from day 10 of menstrual cycle until the follicle reached ≥18 mm
Secondary outcomes (1)
Pregnancy rate
serum B-HCG titre if the patient suffered from amenorrhea
Measured: 2 weeks after follicle reached ≥18 mm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Nov 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 90 female patients will be divided into 3 equal groups: * Group I: 30 female patients with unexplained infertility. * Group II: 30 female patients with unexplained infertility will receive nitroglycerin trans-dermal patch.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Mohamed Abdelrahman, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481582
- Status last verified
- Mar 2018
- First submitted
- 19 Mar 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nitric Oxide Donors on Uterine and Subendometrial Blood Flow in Patients With Unexplained Infertility
- ClinicalTrials.gov ID
- NCT03481582
- Conditions
- Polycystic Ovary Syndrome, Infertility, Female
- Keywords
- Nitroglycerin Trans-dermal Patch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 29 Mar 2018 (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.
The purpose of the study to evaluate effect of nitroglycerin trans-dermal patches on uterine and sub-endometrial blood flow in women with unexplained infertility.
Detailed description
90 female patients will be divided into 2 equal groups:
- Group I: 30 female patients with unexplained infertility.
- Group II: 30 female patients with unexplained infertility will receive nitroglycerin trans-dermal patch.
All subjects will be subjected to the following:
- Proper history taking on past medical history, menstrual history and infertility workup.
- Proper examination (general, abdominal and local examinations)
- Investigations to diagnose unexplained infertility ( male partner's semen analysis as well as documented ovulation and a patent uterine cavity and Fallopian tubes in the female partner).
- Group II (30 patients with unexplained infertility)will receive: (nitrodermal®) 5 mg (patch)as a source of Nitric oxide from 2nd day of cycle till maturation of the follicles ≥ 18 mm just for one cycle
- All women included in each group will be subjected to trans-vaginal ultrasound for folliculometry till maturation of the follicle ≥18mm.
- Once the follicle reached ≥18 mm 3D power Doppler will be used to assess the uterine and sub-endometrial blood flow.
- All women in each group will be subjected to urinary luteinizing hormone (LH) assay. The urinary LH assay will be started on cycle day 11, and repeated daily till detection of the LH surge.
- Six days after detection of the LH surge, 3D power Doppler will be repeated to assess the uterine and sub-endometrial blood flow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 90 female patients will be divided into 3 equal groups: * Group I: 30 female patients with unexplained infertility. * Group II: 30 female patients with unexplained infertility will receive nitroglycerin trans-dermal patch.
| Arm | Type | Receives |
|---|---|---|
| Group without nitroglycerin | Active comparator | Device: Three dimensional power dopplerThey will be subjected to TV ultrasound for folliculometry till maturation of the follicle ≥18mm then Three dimensional power Doppler will be used to assess the uterine and sub-endometrial blood flow. |
| Group with nitroglycerin | Experimental | Drug: Nitroglycerin, Device: Three dimensional power dopplerThey will receive (nitrodermal®) 5 mg (patch) from 2nd day of cycle till maturation of the follicles ≥ 18 mm then Three dimensional power Doppler will be used to assess the uterine and sub-endometrial blood flow. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age between 20-35 years.6
- Normal husband's semen analysis (WHO 2010 Criteria):
- Documented ovulation ( basal body temperature , mid-luteal serum progesterone ≥3 ng / ml and ultrasound monitoring of ovulation).
- Patent Fallopian tube and excluding uterine anomalies either by hystero-salpingogram (HSG) and/or laparoscopy.
- Normal hormonal profile (serum progesterone, E2, F.S.H, LH and T.S.H In the 2ND Day of menstrual cycle)
Key exclusion criteria (14 listed)
- Male factor of infertility.
- Patients with uterine pathology as fibroids.
- Tubal factor of infertility diagnosed by hysterosalpingography (HSG) or laparoscopy.
- Patients with any contraindications for NO such as chronic liver and renal disease, known cardiac disease and migraine.
- Diagnosis of PCO based on Rotterdam criteria, two out of three of the following are required to make the diagnosis (Rotterdam, 2004):
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 |
|---|---|---|
| NitroglycerinAlso: nitrodermal patch(nitrodermal®) 5 mg (patch)as a source of Nitric oxide from 2nd day of cycle till maturation of the follicles ≥ 18 mm just for one cycle. | Drug | Group with nitroglycerin |
| Three dimensional power dopplerOnce the follicle reached ≥18 mm 3D power Doppler will be used to assess the uterine and subendometrial blood flow | Device | Group with nitroglycerin, Group without nitroglycerin |
Primary outcome
Three dimensional power Doppler
Time frame: from day 10 of menstrual cycle until the follicle reached ≥18 mm
Once the follicle reached ≥18 mm 3D power Doppler will be used to assess the uterine and sub-endometrial blood flow
1 secondary outcome
Pregnancy rate
Time frame: 2 weeks after follicle reached ≥18 mm
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 29 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitroglycerin and Three dimensional power doppler in people with Polycystic Ovary Syndrome and Infertility, 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 8 inclusion and 14 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 29 Mar 2018. 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.
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?
Three dimensional power Doppler (time frame: from day 10 of menstrual cycle until the follicle reached ≥18 mm). 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 29 Mar 2018.