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Completed

NCT Number: NCT04846218

Agonist Trigger With HCG Luteal Supplementation vs HCG Trigger With Progesterone Luteal Supplementation in Antagonist Controlled HyperstimulationCycle

The aim of the current study is to compare agonist trigger and HCG luteal support vs standard HCG trigger and progesterone luteal supplementation in antagonist controlled hyperstimulation cycle as regards to clinical pregnancy rate.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

20 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AinShams Maternity Hospital

Cairo, 002, Egypt

About this study

Prospective Interventional randomized pilotstudy on patients undergoing controlled ovarian hyperstimulation.

All patients will receive a fixed dose of 150-300 IU recombinant FSH (Gonal-F; Sereno Laboratories,Madrid, Spain) for ovarian stimulation according to age, BMI and antral follicle count (AFC).

After 6 days of stimulation, FSH will be adjusted according to ovarian response.

Premature LH surge will be prevented with 0.25 mg of a GnRH antagonist (Cetrotide; Serono International, Geneva, Switzerland) starting on day 6 when two or more follicles reach a size of 18-20 mm, trigger of ovulation will be done and followed by luteal phase support according to the protocol assigned for each group.

Group 1:

A single dose of 0.2 mg triptorelin (Decapeptyl® Ipsen Pharmaceutical Company, France) and follow up with daily 125 IU HCG injections

Group 2:

A single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg IM (Prontogest®).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 20 and 39 years.
  • Body mass index between 18 and 30.
  • Unexplained infertility or male factor infertility

Exclusion criteria

  • Endocrinological disorder eg.:hyperprolactenemia, Hypo or hyper thyrodism
  • More than 2 previous attemptsof IVF
  • Any uterine anatomical anomaly.

Treatment and study plan

HCG

Drug

Progesterone

Drug

Other names: Prontogest

Triptorelin

Drug

Other names: Decapeptyl

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 1 year

    Clinical pregnancy diagnosed by pregnancy test and ultrasound

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Comparison Between Agonist Trigger With HCG Luteal Phase Supplementation vs HCG Trigger With Progesterone Luteal Phase Supplementation in Antagonist Controlled HyperstimulationCycle Regarding Clinical Pregnancy Rate

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 15, 2021
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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