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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Sildenafil Vaginal Gel Co-treatment With Clomiphene Citrate on Endometrial Thickness in Infertile Women With Prior Clomiphene Citrate Failure Due to Thin Endometrium: a Prospective Self-cont

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.

Detailed Summary:

Study design:

This is a prospective self-controlled clinical trial.

Study subjects:

Investigators counseled and recruited 42 infertile women who had been diagnosed with anovulatory infertility, with normal baseline FSH, LH, and free testosterone levels, patent tubes on hysterosalpingography, and normal male semen analysis.

By the time they were enrolled in the study, all women had already completed 5 ovulatory cycles of Clomiphene citrate induction (in a dose of 100 mg/ day in two divided doses starting from day 3 of the cycle for 5 days) but without conception (clomiphene citrate failure) with thin endometrium (<8mm) in at least 3 cycles. Ovulation was documented sonographically, and with day-21 serum progesterone exceeding 5 ng/ ml in all cases.

Exclusion criteria:

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 were not included in the study.

Intervention:

Sixth cycle (Clomiphene citrate only):

Enrolled cases were asked to continue with Clomiphene citrate induction ( at the same dose) 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 administration ( when follicular diameter reached 18 mm). Endometrial thickness and Uterine artery Doppler assessment were done in the late proliferative phase ( Day of HCG injection). Sponsor: Assiut University

Current Primary Outcome: Endometrial thickness [ Time Frame: 1 day ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Uterine blood flow [ Time Frame: 1 day ]
    Measuring the pulsatility index in both uterine arteries, and calculating their average value
  • Clinical pregnancy rate [ Time Frame: At the end of a 28-day menstrual cycle. ]
    Identifying pregnancy through positive urinary HCG test plus sonographic detection of cardiac pulsations


Original Secondary Outcome: Same as current

Information By: Assiut University

Dates:
Date Received: March 4, 2016
Date Started: June 2015
Date Completion:
Last Updated: March 16, 2016
Last Verified: March 2016