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Effect of Nitric Oxide Donors on Uterine and Subendometrial Blood Flow in Patients With Unexplained Infertility

Primary Purpose

Polycystic Ovary Syndrome, Infertility, Female

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Nitroglycerin

Three dimensional power doppler

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Nitroglycerin Trans-dermal Patch

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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.
- 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.

Sites / Locations

Department of obstetrics and gynaecology, faculty of medicine, Ain shams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group without nitroglycerin

Group with nitroglycerin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pregnancy rate

serum B-HCG titre if the patient suffered from amenorrhea

Full Information

NCT ID

NCT03481582

First Posted

March 19, 2018

Last Updated

March 27, 2018

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT03481582

Brief Title

Effect of Nitric Oxide Donors on Uterine and Subendometrial Blood Flow in Patients With Unexplained Infertility

Official Title

Effect of Nitric Oxide Donors on Uterine and Subendometrial Blood Flow in Patients With Unexplained Infertility

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

March 1, 2018 (Actual)

Study Completion Date

March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome, Infertility, Female

Keywords

Nitroglycerin Trans-dermal Patch

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantCare Provider

Masking Description

After enrollment, participants would be given the next available number in a computer generated randomization plan . Allocation concealment (among unexplained infertile groups): Opaque, serially-numbered, sealed envelopes will enclose the letter corresponding to the group the patient will follow. Envelopes will be opened when the patient is enrolled and she will receive the intervention accordingly. -Blinding The study design precludes neither participant nor the doctor will be blinded.

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group without nitroglycerin

Arm Type

Active Comparator

Arm Description

Arm Title

Group with nitroglycerin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Nitroglycerin

Other Intervention Name(s)

nitrodermal patch

Intervention Description

(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.

Intervention Type

Device

Intervention Name(s)

Three dimensional power doppler

Intervention Description

Once the follicle reached ≥18 mm 3D power Doppler will be used to assess the uterine and subendometrial blood flow

Primary Outcome Measure Information:

Title

Three dimensional power Doppler

Description

Once the follicle reached ≥18 mm 3D power Doppler will be used to assess the uterine and sub-endometrial blood flow

Time Frame

from day 10 of menstrual cycle until the follicle reached ≥18 mm

Secondary Outcome Measure Information:

Title

Pregnancy rate

Description

serum B-HCG titre if the patient suffered from amenorrhea

Time Frame

2 weeks after follicle reached ≥18 mm

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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. 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.

Facility Information:

Facility Name

Department of obstetrics and gynaecology, faculty of medicine, Ain shams university

City

Cairo

ZIP/Postal Code

11591

Country

Egypt

12. IPD Sharing Statement

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Effect of Nitric Oxide Donors on Uterine and Subendometrial Blood Flow in Patients With Unexplained Infertility

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