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

NCT ID: NCT06297564

Last Updated: 2024-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-01-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Progesterone primed endometrial protocol

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Gonadotropin-releasing hormone antagonist protocol

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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New Valley University

OTHER

Sponsor Role lead

Responsible Party

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Waleed Ahmad Ali

Lecturer of Obstetrics and Gynecology, Faculty of Medicine, New Valley University.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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New Valley University

New Valley, New Valley Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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07/3/9-2023/4

Identifier Type: -

Identifier Source: org_study_id

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