Skip to main content
OpenTrials
Completed

NCT Number: NCT01390207

Earlier Triggering in Rec-FSH/GnRH Antagonist Cycles

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

hCG

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

16mm triggering

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.

Primary outcomes

  1. Ongoing pregnancy rate.

    Time frame: 1 year

Secondary outcomes

  1. number of MII oocytes.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study 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

Acronym: 16mm

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 8, 2011
Registry last updated
Aug 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.