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

NCT06297564 | Completed

• 1 other identifier: 07/3/9-2023/4
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Progesterone Primed Endometrial Protocol; Gonadotropin Releasing Hormone Antagonist Protocol; Assisted Reproductive Treatments

Outcome Measures

Primary Outcomes (1)

• The number of retrieved oocytes

  Retrieved oocytes will be collected after ovarian induction by gonadotropin injection

  34 to 36 hours post HCG administration

Secondary Outcomes (1)

• Pregnancy rate

  Fourteen days following the transfer

Study Arms (2)

Progesterone primed endometrial protocol

ACTIVE COMPARATOR

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

Other: Progesterone primed endometrial protocol

Gonadotropin-releasing hormone antagonist protocol

EXPERIMENTAL

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.

Other: Gonadotropin-releasing hormone antagonist protocol

Interventions

Progesterone primed endometrial protocol OTHER

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.

Progesterone primed endometrial protocol

Gonadotropin-releasing hormone antagonist protocol OTHER

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.

Gonadotropin-releasing hormone antagonist protocol

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: Women undergoing IVF/ICSI cycles with ages of 21 to 40 years, body mass index between 18.5 to 29.9 kg/m2, with previous poor response to conventional prolonged therapy utilizing GnRH agonists (retrieving three oocytes), along with a basal antral follicle count of less than six. .
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• New Valley University: lead

Study Sites (1)

New Valley University

New Valley, New Valley Governorate, 72511, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology, Faculty of Medicine, New Valley University.

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 7, 2024
• Study Start: September 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)