Earlier Triggering in Rec-FSH/GnRH Antagonist Cycles
Information source: Universitair Ziekenhuis Brussel
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: hCG
Intervention: 16mm triggering (Other)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Universitair Ziekenhuis Brussel
Summary
The effect of altering the timing of hCG administration on the ongoing pregnancy rate in
patients stimulated with recombinant-FSH (rec-FSH)/gonadotrophin releasing hormone (GnRH)
antagonists for in vitro fertilisation (IVF).
Clinical Details
Official title: Does Earlier Administration Of Human Chorionic Gonadotropin (hCG) Improve The Probability Of Pregnancy In Cycles Stimulated With Rec-FSH AND GnRH Antagonists? A Prospective Randomized Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Ongoing pregnancy rate.
Secondary outcome: number of MII oocytes.
Detailed description:
Progesterone elevation has been associated with prolongation of the follicular phase in GnRH
antagonists cycles by two days after the commonly used criterion of the presence of at least
three follicles of >or= 17 mm has been met. Such an intervention is associated with
significantly lower ongoing pregnancy rates in GnRH antagonist cycles, without an apparent
deterioration of embryo quality.
The adverse effect of P elevation on the day of hCG administration might be explained by the
induction of differences at the histological level as well as at the gene expression level
between endometrial samples exposed to varying concentrations of progesterone (P).
Prolongation of follicular phase by delaying hCG administration for two days is associated
with a higher incidence of endometrial advancement on the day of oocyte retrieval in GnRH
antagonist cycles (Kolibianakis et al., 2005). Moreover, Vaerenbergh et al., (2011)
demonstrated a distinct difference in endometrial gene expression profile between patients
with progesterone serum concentration above and below the threshold of 1. 5 ng/ml on the day
of HCG administration.
Due to the fact that earlier triggering of final oocyte maturation is expected to result in
lower progesterone levels on the day of hCG administration it might be assumed that such an
intervention might result in an improved probability of pregnancy by leading to a less
deranged and more receptive endometrium.
The purpose of this randomized controlled trial is to evaluate whether triggering of final
oocyte maturation as soon as ≥ 3 follicles ≥ 16mm are present on ultrasound or one day later
affects the probability of pregnancy in patients stimulated with rec-FSH/GnRH- antagonists
for IVF.
Eligibility
Minimum age: 18 Years.
Maximum age: 39 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:- Age ≤ 39 years
- Body mass index between 18 and 29 kg/m²¬
- Presence of both ovaries
- Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1. 6ng/ml) on day one of
the cycle
- Treatment with IVF/ICSI
- Embryo transfer on day 3 (1 or 2 embryos)
- Patients can enter in the study only once
Exclusion Criteria:
- Presence of endometriosis stage ≥3(AFS)
- Polycystic ovarian syndrome (Rotterdam criteria)
- Need for preimplantation genetic diagnosis (PGD)
- Azoospermia testicular sperm extraction (TESE)
Locations and Contacts
Additional Information
Starting date: January 2010
Last updated: August 3, 2011
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