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Trial · Interventional

CompletedPhase 4Registry data

Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients.

NCTNCT04727671 (opens ClinicalTrials.gov in a new tab)Other idPh-CT-4298
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
50 participants (actual)
Sponsor
Damascus University · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Syria

Start
22 Dec 2019
Primary completion
15 Aug 2021
Completion
30 Dec 2021
First posted
27 Jan 2021
Last update posted
24 Oct 2023
Conditions
In Vitro Fertilization · Intracytoplasmic Sperm Injection · Infertility · Polycystic Ovary Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. Ph 4

    Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients.

    NCT04727671

    22 Dec 2019 to 30 Dec 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This prospective, non-randomised, open-label, clinical trial is conducting on polycystic ovary syndrome (PCOS) subjects to compare the effects of two pituitary suppression regimens; GnRH Agonist-Long Protocol and GnRH Antagonist-Flexible Protocol on clinical and embryological IVF/ICSI outcomes, and on the follicular fluid levels of Placental Growth Factor (PlGF); which is known for his pivotal role in the regulation of ovulation, embryo development, and implantation

Interventions

  • Triptorelin acetateDrug
  • CetrorelixDrug
  • recombinant-FSH or recombinant-FSH + human Menopausal GonadotropinDrug
  • Human Chorionic Gonadotropin (hCG)Drug

Arms2

  • Active comparator

    Agonist Group (Long protocol):

    The pituitary down-regulation in this group will be carried out using 0.05-0.1 mg of Triptorelin acetate subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the menstrual cycle until the ovulation triggering day. When the suppressive effect is obtained, ovarian stimulation will commence with recombinant Follicle-Stimulating Hormone (r-FSH) or r-FSH + human Menopausal Gonadotropin (hMG) and the dose will be adjusted according to the ovarian response. Ovulation will be triggered by the administration of 10,000 IU of Human Chorionic Gonadotropin (hCG) when at least three follicles become more than 16-17 mm. After 35±2 hours of ovulation triggering, the oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration. Then they will be prepared to undergo an Intracytoplasmic Sperm Injection (ICSI).

  • Experimental

    Antagonist Group (Flexible protocol):

    The ovarian stimulation in this group will be started with recombinant Follicle-Stimulating Hormone (r-FSH) or r-FSH + human Menopausal Gonadotropin (hMG) on the third day of the menstrual cycle and the dose will be adjusted according to the ovarian response. Initiation of 0.25 mg of GnRH antagonist; Cetrorelix; will take place after detecting a leading follicle diameter ≥ 14 mm. GnRH antagonist administration will be continued till the day of ovulation triggering, which will be accomplished by given 10,000 IU of Human Chorionic Gonadotropin (hCG) when at least three follicles become more than 16-17 mm. After 35±2 hours of ovulation triggering, the oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration. Then they will be prepared to undergo an Intracytoplasmic Sperm Injection (ICSI).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Follicular fluid Placental Growth Factor (PlGF) Concentrations:

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

    Registry description

    Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until assayed using an Elisa kit.

Secondary outcomes(9)

  1. Number of oocytes retrieved

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

    Registry description

    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

    Registry description

    The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.

  3. Maturation Rate%:

    Time frame · Within two hours after oocyte retrieval

    Registry description

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

  4. Fertilization Rate%:

    Time frame · 16-18 hours after microinjection.

    Registry description

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

  5. Cleavage Rate%:

    Time frame · Day 2 after microinjection.

    Registry description

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

  6. Embryo Quality:

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

    Registry description

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

  7. High Quality Embryos rate%:

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

    Registry description

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

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

    Time frame · 2 weeks after embryo transfer

    Registry description

    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.

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

    Time frame · 3-4 weeks after embryo transfer

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 39 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * PCOS women diagnosed according to the Rotterdam criteria 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.

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