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Completed

NCT Number: NCT04727684

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

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.

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Key information

Conditions

In Vitro Fertilization Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Infertility Intracytoplasmic Sperm Injection Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Orient Hospital

Damascus, Syria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PCOS women undergoing IVF/ICSI.
  • Age: 18-39 years.
  • Both ovaries present.

Exclusion criteria

  • Age ≥ 40 years.
  • History of three or more previous IVF failures.
  • Patients with hormonal disorders like hyperprolactinemia, thyroid disorders.
  • Patients who previously undergo Unilateral Oophorectomy.
  • Patients with chronic diseases: diabetes mellitus, cardiovascular diseases, liver diseases, kidney diseases.
  • Patients with diseases may affect IVF outcomes: Endometriosis, uterine fibroids, Hydrosalpinx, Adenomyosis, autoimmune diseases,
  • Cancer.

Treatment and study plan

Triptorelin acetate

Drug

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.

Cetrorelix

Drug

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

recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin

Drug

Dosage adjustment according to the ovarian response.

human chorionic gonadotropin (hCG)

Drug

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.

Primary outcomes

  1. 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

  1. 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.

  2. Number of Metaphase II Oocytes (MII):

    Time frame: Within two hours after oocyte retrieval

    The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.

  3. Number of Metaphase I Oocytes (MI):

    Time frame: Within two hours after oocyte retrieval

    The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.

  4. Number of Germinal Vesicle Oocytes (GV):

    Time frame: Within two hours after oocyte retrieval

    The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.

  5. Number of Atretic Oocytes:

    Time frame: Within two hours after oocyte retrieval

    The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.

  6. Maturation Rate%:

    Time frame: Within two hours after oocyte retrieval

    Maturation Rate is calculated by dividing the number of mature (MII) oocytes by the number of retrieved oocytes.

  7. Fertilization Rate%:

    Time frame: 16-18 hours after microinjection

    Fertilization Rate is calculated by dividing the number of obtained zygote (2PN) by the number of injected oocytes.

  8. Cleavage Rate%:

    Time frame: Day 2 after microinjection

    Cleavage rate is calculated by dividing the number of cleavaged embryos by the number of zygotes (2PN).

  9. Embryo Quality:

    Time frame: Day of transfer (2 or 3 days after microinjection)

    Embryos are assessed using Nikon SMZ1500 stereoscope based on ESHRE criteria (2011).

  10. High Quality Embryos rate%:

    Time frame: Day of transfer (2 or 3 days after microinjection)

    High Quality Embryos rate is calculated by dividing the number of high quality embryos (Grade I) by the total number of cleavaged embryos.

  11. Biochemical Pregnancy Rate% (Per Embryo Transfer):

    Time frame: 2 weeks after embryo transfer

    Biochemical pregnancy is defined as a positive serum beta-hCG pregnancy test after 2 weeks of embryo transfer. The biochemical pregnancy rate is calculated by dividing the number of women who are biochemically pregnant by the number of women who have at least 1 embryo transferred.

  12. Clinical Pregnancy Rate% (Per Embryo Transfer):

    Time frame: 3-4 weeks after embryo transfer

    Clinical pregnancy is defined as the presence of a gestational sac on ultrasound after 3-4 weeks of embryo transfer. The clinical pregnancy rate is calculated as by dividing the number of women who are clinically pregnant divided by the number of women who have at least 1 embryo transferred.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Effect of GnRH Agonist (Long Protocol) vs GnRH Antagonist (Flexible Protocol) on Oocyte Morphology in Polycystic Ovary Syndrome Patients During IVF/ICSI

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2021
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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