Earlier Triggering in Rec-FSH/GnRH Antagonist Cycles

NCT ID: NCT01390207

Last Updated: 2011-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-05-31

Brief 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).

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.

Conditions

hCG

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

16mm follicles

Group Type: EXPERIMENTAL

16mm triggering

Intervention Type: OTHER

Final oocyte maturation will be achieved by administration of 10.000 IU of hCG (Pregnyl®). Randomization will be into 2 groups:

• Group A (early hCG group): hCG will be administrated as soon as ≥ 3 follicles ≥ 16mm were present on ultrasound.

Interventions

16mm triggering

Final oocyte maturation will be achieved by administration of 10.000 IU of hCG (Pregnyl®). Randomization will be into 2 groups:

• Group A (early hCG group): hCG will be administrated as soon as ≥ 3 follicles ≥ 16mm were present on ultrasound.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Center of reproductive medicine-UZ

Other Identifiers

1971

Identifier Type: -

Identifier Source: org_study_id