Clinical trial NCT06879002: Comparing IVF/ICSI Cycle Outcomes of Post Ovulation Ovarian Stimulation Protocol With Elonva Without GnRH Antagonist to Follicular Phase Day 2 Stimulation Fixed Day 5 Antagonist Protocol
Official title: To Compare IVF/ICSI Cycle Outcomes of Post Ovulation Ovarian Stimulation Protocol With Elonva Without GnRH Antagonist to Follicular Phase Fixed Day 5 Antagonist Protocol
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stimulation in the Ovary
IVF Outcome
Keywords: progesterone
premature ovulation
ovarian stimulation
luteal stimulation
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 252
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Expected normal responder patients who undergo IVF/ICSI+PGT-A at ART Fertility Clinics Dubai \& Abu Dhabi are willing to participate in the study.

Brief summary: There are several approaches to the timing of antagonist administration in IVF/ICSI cycles. The primary goal is indeed to prevent premature ovulation, which could jeopardize the success of the cycle There is an emerging concept that suggests that the progesterone produced by the corpus luteum (formed after ovulation) might be sufficient to prevent further ovulation, obviating the need for antagonist or exogenous progesterone administration. This hypothesis relies on the natural regulatory mechanisms of the menstrual cycle to maintain a progesterone-dominated environment post-ovulation. We hypothesized that this approach would minimize treatment costs /burden without having an impact on the outcome.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 38 years old.
* Normal Menstrual cycle of 25-35 days.
* Body Weight 60to90 kg
* AMH\>1.3 - \<3 ng/m (Ferraretti and Gianaroli, 2014; Calzada et al., 2019) an antral follicle count (AFC) of \>5 on menstrual cycle days 2-3,

Exclusion Criteria:

* History of premature ovulation
* Azoospermia
* PCOS
* Endometriosis AFS ¾
* Endometrioma
* Known chromosomal abnormalities

Primary outcomes:
measure: Evaluate the Oocyte maturity, Fertilization rate, Blastulation rate, quality Euploidy rate, Premature ovulation rate, Number of injections used and costs
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: ART Fertility Clinics LLC
city: Dubai
country: United Arab Emirates
facility: ART Fertility Clinics LLC - Dubai
Study officials:
affiliation: ART Fertility Clinics LLC
name: Barbara Lawrenz, PhD
role: STUDY_DIRECTOR
References:
citation: Ata B, Kalafat E. Progestin-primed ovarian stimulation: for whom, when and how? Reprod Biomed Online. 2024 Feb;48(2):103639. doi: 10.1016/j.rbmo.2023.103639. Epub 2023 Oct 22.
citation: Giles J, Cruz F, Garcia-Velasco JA. Progestin-primed ovarian stimulation. Curr Opin Obstet Gynecol. 2024 Jun 1;36(3):165-172. doi: 10.1097/GCO.0000000000000941. Epub 2024 Jan 30.
citation: Glujovsky D, Pesce R, Miguens M, Sueldo CE, Lattes K, Ciapponi A. How effective are the non-conventional ovarian stimulation protocols in ART? A systematic review and meta-analysis. J Assist Reprod Genet. 2020 Dec;37(12):2913-2928. doi: 10.1007/s10815-020-01966-5. Epub 2020 Nov 21.
citation: Kolibianakis EM, Venetis CA, Kalogeropoulou L, Papanikolaou E, Tarlatzis BC. Fixed versus flexible gonadotropin-releasing hormone antagonist administration in in vitro fertilization: a randomized controlled trial. Fertil Steril. 2011 Feb;95(2):558-62. doi: 10.1016/j.fertnstert.2010.05.052. Epub 2010 Jul 16.