NCT04727684·Phase 4·INTERVENTIONAL

Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology in Polycystic Ovary Syndrome Patients During IVF/ICSI

Cetrorelix Other Completed

Status

Completed

Phase

Phase 4

Enrollment

Locations

Results

Not posted

Publications

Study summary

What the protocol is testing.

Selection of developmentally competent oocytes enhances IVF efficiency. Usually, oocyte quality is determined based on its nuclear maturation and the presence of specific cytoplasmic and extracytoplasmic morphologic features. Gonadotropin-releasing hormone agonists (GnRH Agonists) and gonadotropin-releasing hormone antagonists (GnRH Antagonists) are used during controlled ovarian stimulation (COS) protocols in order to prevent premature luteinizing hormone (LH) surge and premature ovulation. However, GnRH receptors are also expressed in extra-pituitary tissues such as ovary, but it is still unknown whether the type of GnRH analogues used during COS could affect the oocyte morphology in polycystic ovary syndrome (PCOS) patients. The aim of this prospective, non-randomised, open-label, clinical trial is to compare the effects of two pituitary suppression regimens; GnRH Agonist-Long Protocol and GnRH Antagonist-Flexible Protocol on oocyte morphology in PCOS patients during IVF/ICSI.

Interventions

Treatment arms and agents.

DRUG

Triptorelin acetate

0.05-0.1 mg subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the cycle until the day of ovulation triggering.

DRUG

Cetrorelix

0.25 mg subcutaneously (SC) once daily starting from the day detecting a leading follicle diameter ≥ 14 mm until the day of ovulation triggering.

DRUG

recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin

Dosage adjustment according to the ovarian response.

DRUG

Human Chorionic Gonadotropin (hCG)

Ovulation will be triggered by the administration of 10,000 IU of human chorionic gonadotropin when at least three follicles become more than 16-17 mm.

Timeline

From registration to results.

First posted
Jan 27, 2021
Study start
Aug 22, 2020
Primary completion
Feb 15, 2022
Study completion
May 12, 2022
Results posted
Not reported
Registry updated
Oct 24, 2023

Outcomes

What the study measures.

Primary outcomes

Prevalence of oocyte dysmorphisms among the studied groups:

Time frame · Before oocytes microinjection

Before being subjected to ICSI, the oocytes from both groups will be morphologically analyzed under an inverted microscope; Nikon Eclipse Ti2; in order to detect cytoplasmic and extra-cytoplasmic dysmorphisms.

Secondary outcomes

Number of oocytes retrieved:

Time frame · Immediately after oocyte retrieval (35±2 hours after hCG administration)

The oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration 35±2 hours after hCG administration.

Number of Metaphase II Oocytes (MII):