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Earlier Triggering in Rec-FSH/GnRH Antagonist Cycles (16mm)

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ClinicalTrials.gov Identifier: NCT01390207
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : August 4, 2011
Sponsor:
Information provided by:
Universitair Ziekenhuis Brussel

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).

Condition or disease Intervention/treatment Phase
hCG Other: 16mm triggering Phase 2 Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2010
Primary Completion Date : April 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 16mm follicles Other: 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.




Primary Outcome Measures :
  1. Ongoing pregnancy rate. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. number of MII oocytes. [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Responsible Party: Kyrou Dimitra, Center of reproductive medicine-UZ
ClinicalTrials.gov Identifier: NCT01390207     History of Changes
Other Study ID Numbers: 1971
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: July 2011

Keywords provided by Universitair Ziekenhuis Brussel:
hCG triggering
pregnancy
GnRH antagonist

Additional relevant MeSH terms:
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs