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NCT04846218 Clinical Trial

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

Infertility, Female Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04846218
Other study ID # AP-45WE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date June 2020

Study information
Verified date November 2021
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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®).

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 39 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• hCG

• Progesterone

• Triptorelin

Locations
Country Name City State
Egypt AinShams Maternity Hospital Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical pregnancy rate Clinical pregnancy diagnosed by pregnancy test and ultrasound 1 year
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