Current partner codePEPTIDESDE
NCT04724343·Phase 4·INTERVENTIONAL

Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes.

Status

Completed

Phase

Phase 4

Enrollment

50

Locations

1

Results

Not posted

Publications

6

Study summary

What the protocol is testing.

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 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

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 (hCG) when at least three follicles become more than 16-17 mm.

Timeline

From registration to results.

  1. First posted

    Jan 26, 2021

  2. Study start

    Dec 22, 2019

  3. Primary completion

    Jan 1, 2022

  4. Study completion

    Jul 5, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Oct 24, 2023

Outcomes

What the study measures.

Primary outcomes

Follicular fluid Placental Growth Factor (PlGF) Concentrations:

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

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 Eliza kit.

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):

Time frame · Within two hours after oocyte retrieval

The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.

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.

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.

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).

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).

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.

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.

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
39 Years
Sex
FEMALE
Healthy volunteers
No

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 ovary 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.

Study locations

1 registered sites.

Syria. Showing up to 24 locations stored in the fast local snapshot.

Orient Hospital

Damascus, Syria

Publications

Results and literature.

PMID 24040457Lai Q, Zhang H, Zhu G, Li Y, Jin L, He L, Zhang Z, Yang P, Yu Q, Zhang S, Xu JF, Wang CY. Comparison of the GnRH agonist and antagonist protocol on the same patients in assisted reproduction during controlled ovarian stimulation cycles. Int J Clin Exp Pathol. 2013 Aug 15;6(9):1903-10. eCollection 2013.PMID 25288473Hoseini FS, Noori Mugahi SM, Akbari-Asbagh F, Eftekhari-Yazdi P, Aflatoonian B, Aghaee-Bakhtiari SH, Aflatoonian R, Salsabili N. A randomized controlled trial of gonadotropin-releasing hormone agonist versus gonadotropin-releasing hormone antagonist in Iranian infertile couples: oocyte gene expression. Daru. 2014 Oct 7;22(1):67. doi: 10.1186/s40199-014-0067-4.PMID 27126581Al-Inany HG, Youssef MA, Ayeleke RO, Brown J, Lam WS, Broekmans FJ. Gonadotrophin-releasing hormone antagonists for assisted reproductive technology. Cochrane Database Syst Rev. 2016 Apr 29;4(4):CD001750. doi: 10.1002/14651858.CD001750.pub4.PMID 27711226Binder NK, Evans J, Salamonsen LA, Gardner DK, Kaitu'u-Lino TJ, Hannan NJ. Placental Growth Factor Is Secreted by the Human Endometrium and Has Potential Important Functions during Embryo Development and Implantation. PLoS One. 2016 Oct 6;11(10):e0163096. doi: 10.1371/journal.pone.0163096. eCollection 2016.PMID 29095972Bender HR, Trau HA, Duffy DM. Placental Growth Factor Is Required for Ovulation, Luteinization, and Angiogenesis in Primate Ovulatory Follicles. Endocrinology. 2018 Feb 1;159(2):710-722. doi: 10.1210/en.2017-00739.PMID 21502182Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology. The Istanbul consensus workshop on embryo assessment: proceedings of an expert meeting. Hum Reprod. 2011 Jun;26(6):1270-83. doi: 10.1093/humrep/der037. Epub 2011 Apr 18.

Primary links

Continue at the source.

Related trials

More studies on Cetrorelix.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.