Gonadotropin-releasing Hormone Antagonist on Triggering Day: A Randomized Controlled Study
Study on the Effect of GnRH Antagonist on hCG Day on Outcomes of Controlled Ovarian Hyperstimulation With GnRH Antagonist Flexible Multiple-dose Protocols
Gonadotropin-releasing hormone (GnRH) antagonists have been widely used for the prevention of premature luteinizing hormone (LH) surges during controlled ovarian hyperstimulation (COH) for in vitro fertilization and embryo transfer (IVF-ET) since the late 1990's.
Many years have passed since GnRH antagonists were introduced to prevent premature LH surges during stimulated cycles. However, there is still no consensus on the optimal GnRH antagonist protocol. Attempts at modifying GnRH antagonist protocols have been made to improve COH outcomes. However, a meta-analysis of 27 randomized controlled trials, including recent reports, showed significantly lower clinical ongoing pregnancy rates in the antagonist group. Thus, additional efforts are needed to identify the optimal stimulation protocols to achieve better follicular and embryonic development and to improve the pregnancy rates in COH using GnRH antagonist.
Given the assumption of a detrimental effect of GnRH antagonist on the pregnancy rate, with current protocols, we hypothesized that a shorter duration of GnRH antagonist administration might improve outcome.
Studieoversigt
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Korea, Republikken, 463-707
- Seoul National University Bundang Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Both ovaries present with no morphological abnormalities
- Normal ovulatory cycle with cycle lengths of between 25 and 35 days
- Basal serum FSH (day 3) level of < 15 mIU/mL
- Body mass index (BMI) ranging between 18 and 27 kg/m2
Exclusion Criteria:
- History of a poor ovarian response
- Evidence of endocrine abnormalities, such as, hyperprolactinemia, thyroid dysfunction, or polycystic ovary syndrome
- Hydrosalpinx
- Severe endometriosis (stage III-IV)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: A
Stimulated as conventional protocol
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The GnRH antagonist, cetrorelix acetate (Cetrotide; Serono) 0.25 mg was added daily, starting when the leading follicle reached 14 mm in diameter during ovarian stimulation for IVF.
When the leading follicle reached a mean diameter of 18 mm or two follicles or more reached a diameter of 17 mm, 250 μg of recombinant hCG (Ovidrel; Serono) SQ was injected.
In Group A, the GnRH antagonist continued to be used until the day of hCG administration.
In Group B, the GnRH antagonist was not administrated on the hCG day
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Eksperimentel: B
GnRH antagonist stopped one day earlier than conventional protocol
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The GnRH antagonist, cetrorelix acetate (Cetrotide; Serono) 0.25 mg was added daily, starting when the leading follicle reached 14 mm in diameter during ovarian stimulation for IVF.
When the leading follicle reached a mean diameter of 18 mm or two follicles or more reached a diameter of 17 mm, 250 μg of recombinant hCG (Ovidrel; Serono) SQ was injected.
In Group A, the GnRH antagonist continued to be used until the day of hCG administration.
In Group B, the GnRH antagonist was not administrated on the hCG day
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Maturity of oocytes, fertilization rate, embryo quality
Tidsramme: 3 days
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3 days
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Chang Suk Suh, M.D., Ph.D., Dept. of Obstetrics and Gynecology, Seoul National University Bundang Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B-0710-050-001
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Kliniske forsøg med cetrorelix acetate
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Università degli Studi 'G. d'Annunzio' Chieti e...Ukendt
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University of OxfordOxford Fertility Limited, United KingdomUkendt
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Bio Genuine (Shanghai) Biotech Co., Ltd.Ikke rekrutterer endnuAssisteret reproduktionsteknologi | Kontrolleret ovariehyperstimuleringKina
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ClinAmygateCairo University; Al-Azhar University; Beni-Suef UniversityAfsluttetOvarialt hyperstimuleringssyndromEgypten
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Western University, CanadaIkke rekrutterer endnu
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Peking University Third HospitalRekruttering
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University of Colorado, DenverNational Heart, Lung, and Blood Institute (NHLBI)AfsluttetOvergangsalderen | AldringForenede Stater
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Peking University Third HospitalRekruttering
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Peking University Third HospitalIkke rekrutterer endnuInfertilitet, kvinde
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EMD SeronoAfsluttetInfertile kvinder, der gennemgår assisteret reproduktionsteknologi (ART)