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

Not Applicable

Completed

• Conditions: Infertility, Female
• Interventions: Drug: hCG; Drug: Progesterone; Drug: Triptorelin

• Registration Number: NCT04846218
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed 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®).

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-31
• Primary Completion: 2020-01
• Study Completion: 2020-06
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-17
• Last Update Posted: 2021-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Progesterone	They will receive a single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg IM (Prontogest®).
Group 1	hCG	They will receive a single dose of 0.2 mg triptorelin (Decapeptyl® Ipsen Pharmaceutical Company, France) and follow up with daily 125 IU HCG injections
Group 2	hCG	They will receive a single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg IM (Prontogest®).
Group 1	Triptorelin	They will receive a single dose of 0.2 mg triptorelin (Decapeptyl® Ipsen Pharmaceutical Company, France) and follow up with daily 125 IU HCG injections

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	1 year	Clinical pregnancy diagnosed by pregnancy test and ultrasound

Trial Locations

Locations (1)

AinShams Maternity Hospital; 🇪🇬 Cairo, Egypt