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

New Valley University

Status: Completed

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

Treatments: Other: Gonadotropin-releasing hormone antagonist protocol; Other: Progesterone primed endometrial protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT06297564

07/3/9-2023/4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Progesterone primed endometrial protocol

Active Comparator group

Description:

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

Treatment:

Other: Progesterone primed endometrial protocol

Gonadotropin-releasing hormone antagonist protocol

Experimental group

Description:

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.

Treatment:

Other: Gonadotropin-releasing hormone antagonist protocol