Sildenafil Citrate in Frozen Embryo Transfer

NCT02845388 | Completed Phase 2 DMC

• 1 other identifier: Ainshams2015Omar
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparison between usage of Sildenafil citrate with estradiol valerate or estradiol valerate alone in endometrial preparation and outcome of frozen-thawed embryo transfer cycles.

Conditions

Infertility

Keywords

IVF

Outcome Measures

Primary Outcomes (1)

• endometrial pattern

  Endometrial pattern will be trilaminar or bilaminar after it's preparation with estradiol valerate alone or estradiol valerate and sildenafil citrate. Endometrial pattern will be estimated by transvaginal ultrasonography for trilaminar pattern every other day from 8th day till 12th day of the menstrual cycle.

  starting from 8th day till 12th day of the menstrual cycle

Secondary Outcomes (2)

• endometrial thickness

  starting from 8th day till 12th day of menstrual cycle

• biochemical pregnancy test

  2 weeks after embryo transfer

Study Arms (2)

estradiol valerate

ACTIVE COMPARATOR

estradiol valerate 2mg every 12 hours orally starting from the second day of the menstrual cycle till reaching trilaminar endometrial pattern and endometrial thickness 8 mm or more

Drug: estradiol valerate

Sildenafil citrate and estradiol valerate

ACTIVE COMPARATOR

Sildenafil citrate 25 mg every 6 hours orally in combination with estradiol valerate 2mg every 12 hours orally starting from the second day of the menstrual cycle till reaching trilaminar endometrial pattern and endometrial thickness 8 mm or more

Drug: Sildenafil citrate; Drug: estradiol valerate

Interventions

Sildenafil citrate DRUG

Also known as: Viagra

Sildenafil citrate and estradiol valerate

estradiol valerate DRUG

Sildenafil citrate and estradiol valerate; estradiol valerate

Eligibility Criteria

• Age: 20 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• all cases have at least 2 good quality blastocysts available for transfer

You may not qualify if:

• uterine structural abnormalities
• advanced uterine disease
• hydrosalpinx and pyosalpinx

Sponsors & Collaborators

• Omar Ahmed El Sayed Saad: lead

MeSH Terms

Conditions

Infertility

Interventions

Sildenafil Citrate; Estradiol

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Alaa mohamed elghannam, professor

  department of obstetric and gynacology Ain shams university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident of obstetric and gynecology in Shebin Elkom teaching hospital

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 27, 2016
• Study Start: September 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 27, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share