Sildenafil and Outcome of IVF/ICSI Cycles
The Effect of Vaginal Sildenafil on the Outcome of IVF/ICSI Cycles in Patients With Repeated IVF/ICSI Failure: a Pilot Study
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 30, 2017
CompletedFirst Posted
Study publicly available on registry
June 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedJune 20, 2017
April 1, 2017
2.5 years
April 30, 2017
June 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Implantation rate
4-6 weeks
Endometrial thickness
1 day
Endometrial pattern
Day 14
Pulsatility index
1 day
Resistance index (RI)
1 day
Study Arms (3)
A
EXPERIMENTALSildenafil vaginal suppositories users
B
PLACEBO COMPARATORDaily vaginal placebo users with HMG administration
C
PLACEBO COMPARATORDaily vaginal placebo users with HMG administration day until the day of oocyte retrieval.
Interventions
Sildenafil vaginal suppositories (100 mg/day) from the start of HMG administration day until the day of oocyte retrieval.
Daily vaginal placebo from the start of HMG administration day until 2 days before the hCG injection day, then will be switched to vaginal sildenafil suppositories (100 mg/day) until the day of oocyte retrieval.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Women who had history of PCOS, myomectomy, Asherman's Syndrome and mullerian anomalies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royan Institutelead
- Tehran University of Medical Sciencescollaborator
Study Sites (1)
Royan Institute
Tehrān, Iran
Related Publications (1)
Moini A, Zafarani F, Jahangiri N, Jahanian Sadatmahalleh SH, Sadeghi M, Chehrazi M, Ahmadi F. The Effect of Vaginal Sildenafil on The Outcome of Assisted Reproductive Technology Cycles in Patients with Repeated Implantation Failures: A Randomized Placebo-Controlled Trial. Int J Fertil Steril. 2020 Jan;13(4):289-295. doi: 10.22074/ijfs.2020.5681. Epub 2019 Nov 11.
PMID: 31710189DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hamid Gourabi, PhD
Head of Royan Institute
- STUDY DIRECTOR
Ashraf Moieni, MD
Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
- PRINCIPAL INVESTIGATOR
Firoozeh Ahmadi, MD
Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
- PRINCIPAL INVESTIGATOR
Fatemeh Zafarani, MSc
Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2017
First Posted
June 20, 2017
Study Start
February 1, 2015
Primary Completion
August 1, 2017
Study Completion
September 1, 2017
Last Updated
June 20, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share