N/A
N=42
Sildenafil Vaginal Gel Co-treatment With Clomiphene Citrate in Infertile Women With Thin Endometrium
Anovulation
Bottom Line
View on ClinicalTrials.gov: NCT02710981 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Endometrial Thickness — 6.6; 9.3 millimeter
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- clomiphene citrate (Drug); Sildenafil vaginal gel (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Assiut University
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endometrial Thickness |
6.6; 9.3 | — |
| SECONDARY Uterine Blood Flow |
2.4; 1.6 | — |
| SECONDARY Clinical Pregnancy Rate |
0; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
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
Data sourced from ClinicalTrials.gov (NCT02710981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.