Sildenafil Vaginal Gel Co-treatment With Clomiphene Citrate in Infertile Women With Thin Endometrium

NCT02710981 | Completed Results

• 1 other identifier: AUH1
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective self controlled clinical trial. Women with clomiphene Citrate failure, and thin endometrium were recruited (N = 42). In their 6th (Clomiphene citrate only) cycle, women continued on Clomiphene citrate 100 mg/ day for 5 days, and had sonographic measurement of their endometrial thickness , and Doppler evaluation of their uterine arteries on the day of HCG administration. In 7th cycle, women (N = 36) were given usual dose of Clomiphene citrate supplemented with sildenafil vagina gel (5 gm, containing 50 mg sildenafil) twice daily from cycle day 8 till the day of HCG injection. Endometrial thickness and uterine artery Doppler were measured on the day of HCG administration.

Conditions

Anovulation

Keywords

Sildenafil vaginal gel; endometrium; clomiphene; anovulation

Outcome Measures

Primary Outcomes (1)

• Endometrial Thickness

  Transvaginal sonographic measurement of maximal distance spanning endometrial- myometrial interphase on each endometrial stripe in a sagittal plane in the fundus of the uterus

  Day of HCG administration

Secondary Outcomes (2)

• Uterine Blood Flow

  Day of HCG administration

• Clinical Pregnancy Rate

  At the end of a 28-day menstrual cycle.

Study Arms (2)

Clomiphene citrate only

ACTIVE COMPARATOR

women with prior 5 ovulatory cycles of Clomiphene citrate induction, but without conception (clomiphene citrate failure), with thin endometrium (\<8mm) in at least 3 cycles.

Drug: clomiphene citrate

Sildenafil vaginal gel and Clomiphene

EXPERIMENTAL

Women who did not conceive on the Clomiphene citrate only cycle (41 women) were given Clomiphene citrate 100 mg/ day starting from day of the cycle for 5 days, with the addition to sildenafil vaginal gel 5 gm twice daily starting from day 8 of the cycle until day of HCG injection.

Drug: clomiphene citrate; Drug: Sildenafil vaginal gel

Interventions

clomiphene citrate DRUG

Clomiphene citrate only arm: Patients received Clomiphene citrate induction ( (in a dose of 100 mg/ day in two divided doses starting from day 3 of the cycle for 5 days) for the 6th cycle. A gel base, without medicament (vehicle only), was applied vaginally in a dose of 5 gm twice per day, from cycle day 8 to the day of HCG injection. Sonographic assessment of endometrial thickness together with Uterine artery Doppler evaluation were done in the late proliferative phase ( Day of HCG injection).

Also known as: clomid only

Clomiphene citrate only; Sildenafil vaginal gel and Clomiphene

Sildenafil vaginal gel DRUG

In addition to clomiphene citrate treatment as the previous group, women in the second arm were prescribed sildenafil vaginal gel in a dose of 5 g gel applied vaginally twice daily from cycle day 8 to the day of HCG injection. The sildenafil vaginal gel consists of sildenafil acetate as a medicament loaded on an in situ gelling system based on two polymers: Pluronic p-127, and Hydroxy Ethyl Cellulose.The gel was prepared in collaboration with the department of pharmaceutics, faculty of Pharmacy, Assiut University. Sixty grams of gel were prepared in tubes and every patient was given 10 applicators like that used for administration of vaginal antimycotic creams to use them for applying the gel.

Also known as: Viagra vaginal gel

Sildenafil vaginal gel and Clomiphene

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with clomiphene citrate failure (defined as at least prior 5 ovulatory cycles with clomiphene citrate, with no conception),
• persistently thin endometrium (less than 8 mm in at least 3 cycles).
• normal baseline FSH, LH, and free testosterone levels, patent tubes on hysterosalpingography, and normal male semen analysis

You may not qualify if:

• Women with major medical problems,
• male factor infertility,
• endocrine abnormalities such as hyperprolactinemia or abnormal thyroid functions,
• prior ovarian or adnexal surgery, or organic pelvic pathology

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Anovulation

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Essam R. Othman
• Organization: OB-GYN department, Assiut University, Egypt

essamrash@yahoo.com

+201006607801

Study Officials

• Ahmed N. Fetih, M.D.

  Assiut University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 17, 2016
• Study Start: June 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 5, 2020
• Results First Posted: May 5, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share