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
NCT ID: NCT06879002
Last Updated: 2025-10-02
Study Results
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Basic Information
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NOT_YET_RECRUITING
252 participants
OBSERVATIONAL
2025-12-30
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Group A: - Follicular phase start of ovarian stimulation with Elonva
Patients considered for ovarian stimulation for IVF/ICSI will be informed and a CF will be given on the day of planning for IVF. In group one, the ovarian stimulation protocol would follow a fixed GnRH antagonist protocol with recombinant FSH, Corifolitropin alfa (Elova150 mcg) starting on day 2 of the menstrual cycle.
Group A: Day 2-3 of cycle: Estradiol, Progesterone, Luteinizing Hormone, Follicle stimulating hormone During stimulation: on day 8 of stimulation: Estradiol, Progesterone, Luteinizing Hormone, Follicle stimulating hormone on trigger day: Estradiol, Progesterone, Luteinizing Hormone, Follicle stimulating hormone
Final oocyte maturation will be administered when 3 follicles reach 17mm or more. Oocyte retrieval will be performed 36 hours after human chorionic gonadotropin (hCG5000 or 10000IU, choriomon, IBSA) plus GnRH-a (0.2 or 0.3 mg Gonapeptyl, Ferring) administration under transvaginal ultrasound guidance.
Ovarian stimulation with menstruation or after ovulation
Ovarian stimulation with menstruation or after ovulation
Group B: One day after the Positive LH kit test at home: E2 P4 LH FSH,BHCG
. In group two, Elona 150mcg is being administered after ovulation confirmation with home LH kits starting to be used around usual ovulation days, and be confirmed in clinic with LH rise, E2 drop and blood P4 more than 1ng/dl one day after LH kit is positive. The probability of spontaneous pregnancy will be ruled out by betaHCG test. In case a spontaneous pregnancy has been confirmed,we will not start the treatment . Furthermore, in case of sustained progesterone rise,repeated hCG tests will be performed throughout the stimulation cycle to monitor whether there is an early pregnancy or not. If so,the treatment will be cancelled/stopped to prevent the potential risks of stimulation medications during an early pregnancy.From stimulation Day 8 onwards, hormonal stimulation will continue with daily dose. The maximum injection dose for continuing treatment after the first 7 days will be 200 IU. (10) Final oocyte maturation will be administered when 3 follicles reach 17mm or more.
Ovarian stimulation with menstruation or after ovulation
Ovarian stimulation with menstruation or after ovulation
Interventions
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Ovarian stimulation with menstruation or after ovulation
Ovarian stimulation with menstruation or after ovulation
Eligibility Criteria
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Inclusion Criteria
* 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
* Azoospermia
* PCOS
* Endometriosis AFS ¾
* Endometrioma
* Known chromosomal abnormalities
18 Years
38 Years
FEMALE
Yes
Sponsors
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ART Fertility Clinics LLC
OTHER
Responsible Party
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Maryam Farid Mojtahedi
Specialist IVF
Principal Investigators
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Barbara Lawrenz, PhD
Role: STUDY_DIRECTOR
ART Fertility Clinics LLC
Locations
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ART Fertility Clinics LLC
Abu Dhabi, , United Arab Emirates
ART Fertility Clinics LLC - Dubai
Dubai, , United Arab Emirates
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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2409-ABU-015-MF
Identifier Type: -
Identifier Source: org_study_id
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