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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06297564
Enrollment
40
Registered
2024-03-07
Start date
2022-09-01
Completion date
2024-01-01
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERProgesterone 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.

OTHERGonadotropin-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.

Sponsors

New Valley University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The number of retrieved oocytes34 to 36 hours post HCG administrationRetrieved oocytes will be collected after ovarian induction by gonadotropin injection

Secondary

MeasureTime frameDescription
Pregnancy rateFourteen days following the transferBiochemical 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%

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026