Current partner codePEPTIDESDE
NCT00823472·Phase 4·INTERVENTIONAL

Trial Comparing Start Stimulation of Recombinant Follicle Stimulating Hormone (rFSH) on Cycle Day 2 Versus Cycle Day 5 in In Vitro Fertilization (IVF)

Status

Terminated

Phase

Phase 4

Enrollment

147

Locations

2

Results

Posted

Publications

1

Study summary

What the protocol is testing.

Background of the study: Milder stimulation protocols have the advantage of being less expensive and more patient-friendly. Moreover, recent evidence suggests that mild stimulation protocols lead to lower embryo aneuploidy rates compared to conventional treatment regimens. Although with mild stimulation protocols the expected number of oocytes retrieved will be lower, pregnancy rates have shown to be similar possibly because embryo quality outfavours embryo quantity. Objective of the study: The aim of the study is to determine whether cycle day (CD) 5 start of stimulation will lead to better quality of embryos, based on morphology, than CD 2 start, in IVF with GnRH antagonist co-treatment started on a fixed day. Study design: Prospective randomized trial comparing two different starting days of ovarium stimulation (day 2 versus day 5) for IVF treatment. Intervention: One group wil start on cycle day 2 with stimulation of the ovaries with recombinant FSH. The other group will start on cycle day 5. Both group will start suppressing the gonadotrophin production of the the pituitary gland on cycle day 6 with a GnRH antagonist. Primary study parameters/outcome of the study: Primary outcome parameter is number of top embryos per ovum pick up. Secondary study parameters/outcome of the study: Secondary outcome measures are duration of stimulation, cancellation rate, fertilization rate, number of cumulus oocyte complexes obtained, number of mature oocytes obtained, number of top embryos per started cycle, amount of IU recFSH, and clinical pregnancy rate.

Interventions

Treatment arms and agents.

DRUG

Mild stimulation

Fixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm

Timeline

From registration to results.

  1. First posted

    Jan 15, 2009

  2. Study start

    Jan 2009

  3. Primary completion

    Oct 2010

  4. Study completion

    Oct 2010

  5. Results posted

    Dec 2, 2010

  6. Registry updated

    Jan 29, 2019

Outcomes

What the study measures.

Primary outcomes

Proportion of Top Embryos Per OPU.

Time frame · 1 year

Proportion of top embryos per ovum pick-up

Secondary outcomes

Number of Cumulus Oocyte Complexes Obtained

Time frame · one year

Number of cumulus oocyte complexes obtained after ovum pick-up

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
36 Years
Sex
FEMALE
Healthy volunteers
Yes

Inclusion Criteria: * Female age \< 36 years * FSH \< 12 IU/l * BMI 18-29 kg/m2 * Regular cycle (25-35 days) * No major uterine or ovarian abnormalities * No previous IVF cycles * Written informed consent Exclusion Criteria: * Oocyte donation * Medical contra indication for pregnancy or IVF treatment * Endometriosis ≥ grade 3 * Polycystic Ovarium Syndrome (PCOS) * Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)

Study locations

2 registered sites.

Belgium · Netherlands. Showing up to 24 locations stored in the fast local snapshot.

UZ Brussel

Brussels, Belgium

University Medical Center Utrecht

Utrecht, Netherlands

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Put the record in context.

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