Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology During IVF/ICSI

NCTNCT04724486Other idPh-CT-4301

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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 Aug 2020
Primary completion: 15 Mar 2022
Completion: 15 Jul 2022
First posted: 26 Jan 2021
Last update posted: 24 Oct 2023
Conditions: In Vitro Fertilization · Intracytoplasmic Sperm Injection · Infertility

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2020202120222023

Ph 4
Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology During IVF/ICSI
NCT04724486
22 Aug 2020 to 15 Jul 2022

Registry summary

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

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, especially with the limited and conflicted currently available data. Thus, we are conducting this prospective, non-randomised, open-label, clinical trial to compare the effects of two pituitary suppression regimens; GnRH Agonist-Long Protocol and GnRH Antagonist-Flexible Protocol on oocyte morphology during IVF/ICSI.

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.

Prevalence of oocyte dysmorphisms among the studied groups:
Time frame · Before oocytes microinjection
Registry description
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(12)

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.
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.
Number of Metaphase I Oocytes (MI):
Time frame · Within two hours after oocyte retrieval
Registry description
The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.
Number of Germinal Vesicle Oocytes (GV):
Time frame · Within two hours after oocyte retrieval
Registry description
The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.
Number of Atretic Oocytes:
Time frame · Within two hours after oocyte retrieval
Registry description
The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.
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.
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.
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).
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).
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.
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.
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.

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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: * 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 with Polycystic Ovarian Syndrome. * 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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