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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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in Vitro Fertilization Ovulation Induction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Start rFSH cycle day 2

Group Type EXPERIMENTAL

Mild stimulation

Intervention Type DRUG

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

Start rFSH on cycle day 5

Group Type EXPERIMENTAL

Mild stimulation

Intervention Type DRUG

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

Interventions

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Mild stimulation

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

Intervention Type DRUG

Other Intervention Names

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Puregon Ganirelix

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes