Progesterone Primed Endometrial Protocol Versus Gonadotropin-releasing Hormone Antagonist Protocol in Assisted Reproductive Treatments

Not Applicable

Completed

• Conditions: Gonadotropin Releasing Hormone Antagonist Protocol; Assisted Reproductive Treatments; Progesterone Primed Endometrial Protocol
• Interventions: Other: Progesterone primed endometrial protocol; Other: Gonadotropin-releasing hormone antagonist protocol

• Registration Number: NCT06297564
• Lead Sponsor: New Valley University

Brief Summary

The aim of this study was to compare the clinical outcomes in progesterone primed endometrial protocol versus gonadotropin-releasing hormone antagonist protocol in women undergoing assisted reproductive treatments.

Detailed Description

Utilizing the assisted reproductive techniques (ART) has exhibited a substantial rise within the last years, emerging as a crucial modern medicine component with reliable results.

The utilized protocols for endometrial preparation in ART are aimed at maximizing the treatments' success. Typically, utilizing gonadotropin-stimulating hormone (GnRH) antagonists or agonists remains involved for preventing an early luteinizing hormone (LH) peak along ovulation prior to oocytes retrieval.

The GnRH-antagonist (GnRH-a) protocol is favored by many clinicians as well as patients due to its simplicity, convenience, flexibility, and absence of functional ovarian cysts or "menopausal" symptoms linked to the agonist protocol. Nevertheless, some RCTs' findings address that the antagonist protocol yields a reduced oocytes' number. Additionally, it exhibits lower pregnancy rates as opposed to the agonist extended therapy.

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-29
• Last Update Submitted: 2024-02-29
• Study First Posted: 2024-03-07
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Age 21 to 40 years.
• A basal antral follicle count (AFC) <6.
• All patients had to have a body mass index between 18.5 to 29.9 kg/m2.
• Undergoing IVF/ICSI cycles.
• With previous poor response to conventional prolonged therapy utilizing GnRH agonists (retrieving three oocytes).

Exclusion Criteria

• Cycles with fresh embryo transfer.
• Transfers of cleavage embryos (d2/d3).
• Embryos from cycles with preimplantation genetic screening.
• Cryopreservation of oocytes.
• Oocyte donation cycles.
• Cycles that produced embryos but without et at the time of the analysis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progesterone primed endometrial protocol	Progesterone primed endometrial protocol	The cases were received soft progesterone capsules (brand name: Utrogestan, 100 mg, Laboratories Besins International, France) 100 mg and 150 IU of human menopausal gonadotropin (hMG) concomitantly from the menstrual cycle (MC) day 3 until the trigger day
Gonadotropin-releasing hormone antagonist protocol	Gonadotropin-releasing hormone antagonist protocol	The cases were received the gonadotropin-releasing hormone antagonist (GnRH-ant) protocol consisting of HMG 150 IU's daily injection from MC 3 until the trigger day. GnRH-ant (Cetrotide, 0.25 mg, MerckSerono) was started when at least one of the following criteria were met: LH \>10 IU/L, the presence of at least one follicle with mean diameter \>14 mm, or serum E2 level \>600 pg/mL.

Primary Outcome Measures

Name	Time	Method
The number of retrieved oocytes	34 to 36 hours post HCG administration	Retrieved oocytes will be collected after ovarian induction by gonadotropin injection

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate	Fourteen days following the transfer	Biochemical pregnancy was determined as serum HCG higher than 25 mIU/ml at twelve to fourteen days following the transfer. Gynecological ultrasound assessment was accomplished at thirty to thirty-five following the transfer. Additionally, the gestational sac existence was regarded as clinical pregnancy, with the clinical pregnancy rate = (clinical pregnancy cycles' number/ all transfer cycles' number) × 100%. Moreover, live birth rate equals (live birth cycles' number/ all transfer cycles' number) × 100%

Trial Locations

Locations (1)

New Valley University; 🇪🇬 New Valley, Egypt