Infertility, Female Clinical Trial
Official title:
The Effect of Vaginal Sildenafil on the Outcome of IVF/ICSI Cycles in Patients With Repeated IVF/ICSI Failure: a Pilot Study
Adequate growth of the endometrium is crucial for implantation. Accordingly, the pregnancy success rate of patients with a thin endometrium is low. Furthermore, there is a little information about the factors responsible for impaired endometrial growth in patients with a thin endometrium. The researches have revealed that nitric oxide (NO) release can cause relaxation of vascular smooth muscle through a cyclic guanyl monophosphate (cGMP)-mediated pathway. Sildenafil is a type 5-specific Phosphodiesterase inhibitor that augments the vasodilatory effects of NO on vascular smooth muscle by preventing the degradation of cGMP and could improve blood flow and endometrial thickness. This study is designed to evaluate the effect of vaginally administered sildenafil suppositories on IVF/ICSI outcome of infertile patients with repeated IVF/ICSI failures.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | September 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 16 Years to 38 Years |
Eligibility |
Inclusion Criteria: - Women with normal ovarian reserve and had at least two prior cycle with FSH <10 mIu/ml - Women with history of two or three prior consecutive failed IVF/ICSI attempts using at least two good quality fresh or frozen-thawed embryos. - Endometrial thickness on the day of hCG injection was < 9 mm in all prior IVF/ICSI attempts - Women with normal endometrial appearance in hysteroscopy or hysterosonography or hysterosalpingography Exclusion Criteria: - Women who had history of PCOS, myomectomy, Asherman's Syndrome and mullerian anomalies |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Royan Institute | Tehran |
Lead Sponsor | Collaborator |
---|---|
Royan Institute | Tehran University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Pregnancy rate | Evaluation the Clinical Pregnancy rate after using Sildenafil vaginal suppositories (100 mg/day) from the start of HMG administration day until the day of oocyte retrieval. It is detected by a positive ß-hCG test result and ultrasonographic visualization of at least one gestational sac | 4-6 weeks after embryos transfer | |
Secondary | Implantation rate | The implantation rate is defined as number of gestational sacs per transferred embryo. It Is detected by a positive ß-hCG test result and ultrasonographic visualization of at least one gestational sac 4-6 weeks after embryos transfer. | 4-6 weeks | |
Secondary | Endometrial thickness | The endometrial thickness is detected by ultrasound examination in hCG day administration. | 1 day | |
Secondary | Endometrial pattern | Comparing gray scale appearance of the endometrium to that of the adjacent myometrium at Day 14 of previous cycle. | Day 14 | |
Secondary | Pulsatility index | The variability in flow between the systole and the diastole; this measure was calculated by dividing the difference between the peak systolic and end-diastolic frequencies by the time-average of the maximum frequency shift.This is measured at hCG administration day. | 1 day | |
Secondary | Resistance index (RI) | The RI is defined as a ratio of the difference between the maximum and minimum flow velocity to maximum flow velocity.This is measured at hCG administration day. | 1 day |
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