Effect Sildenafil and Estradiiol Valerate on Endometrial Thickness in Infertile Women

NCT03301233 | Completed

• 1 other identifier: 2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The endometrium is a dynamic tissue that responds to changing hormonal signals throughout the cycle. The changes in the endometrial composition are expressed in alteration in gene expression, micro architectural morphological changes as well as in protein and hormone secretion. These factors combine together to construct the "window of implantation" a short period of time during the luteal phase in which the endometrium is receptive. Thin endometrium is associated with a low pregnancy rate. Endometrial thickness 7 mm in the pre-ovulatory phase is widely accepted to be cut-off of thin endometrium. for that the aim of this study is to compare the effect of sildenafil-estrogen combination to estrogen alone on endometrium thickness in infertile women. Half of the patients will receive estrogen ( estradiol valerate ) and the other half will receive combination of sildenafil-estrogen .

Conditions

Endometrial Thickness

Outcome Measures

Primary Outcomes (1)

• endometrial line thickness

  The thickness of the endometrium will be measured (maximum distance between each myometrial/endometrial interface through the longitudinal axis of the uterus) using two dimensional transvaginal ultrasound.

  9 days

Secondary Outcomes (2)

• positive pregnancy test

  14 days after triggering of ovulation

• sub endometrial blood flow

  9 days

Study Arms (2)

estradiol valerate

ACTIVE COMPARATOR

oral estradiol valerate (Cyclo-Progynova ® 2mg, white tablets, BAYER Schering Pharma). One tablet every 12 hour from 2nd day of the cycle till the day of trigger of ovulation).

Drug: estradiol valerate and sildenafil

estradiol valerate and sildenafil

EXPERIMENTAL

oral estradiol valerate (Cyclo-Progynova ® 2mg, white tablets, BAYER Schering Pharma), one tablet every 12 hour from 2nd day of the cycle + sildenafil (silden® 25 mg, E.I.P.I.CO.) every 8 hour from 2nd day of the cycle till the day of trigger of ovulation).

Drug: estradiol valerate and sildenafil

Interventions

estradiol valerate and sildenafil DRUG

(45 women will receive clomiphene citrate (clomid 50mg ®, Sanofi aventis) 2 tab. single dose orally from the 2nd day of the cycle for 5 days with oral estradiol valerate (Cyclo-Progynova ® 2mg, white tablets, BAYER Schering Pharma), one tablet every 12 hour from 2nd day of the cycle + sildenafil (silden® 25, E.I.P.I.CO.) every 8 hour from 2nd day of the cycle till the day of trigger of ovulation).

Also known as: cycloprogenova and silden

estradiol valerate; estradiol valerate and sildenafil

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients having ovulatory infertility.
• Age: 20-35 years old.
• BMI less than 30 kg/m2

You may not qualify if:

• Women who have any congenital uterine anomaly (e.g., unicornuate uterus or infantile uterus) or acquired deformities of the uterine cavity that interfere with embryo implantation (as Asherman Syndrome).
• Women who have any tubal factor that relates to infertility (e.g., tubal adhesion or previous ectopic pregnancy).
• Women who have contraindication for estrogen treatment (e.g., history of stroke, DVT and Benign liver disease).
• Women who have male factor for infertility (e.g., azoospermia, teratospermia).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Estradiol; Sildenafil Citrate

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hayam F Mohammad, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Ninety opaque envelopes will be numbered serially and in each envelope the corresponding letter which denotes the allocated group will be put according to randomization table. Then all envelopes will be closed and put in one box. When the first patient arrives, the first envelope will be opened and the patient will be allocated according to the letter inside.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology , Ain Shams University

Study Record Dates

• First Submitted: September 24, 2017
• First Posted: October 4, 2017
• Study Start: November 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 30, 2018
• Last Updated: August 14, 2018

Record last verified: 2018-08

Locations

EG (1)