Clinical trial NCT00823472: Trial Comparing Start Stimulation of Recombinant Follicle Stimulating Hormone (rFSH) on Cycle Day 2 Versus Cycle Day 5 in In Vitro Fertilization (IVF)
Official title: Among IVF Patients Undergoing Fixed Antagonist Protocols With Recombinant FSH, Does Administration of Recombinant FSH From Cycle Day 5 Onwards Compared With Cycle Day 2 Onwards, Yield a Higher Number of Good Quality Embryos?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: in Vitro Fertilization
Ovulation Induction
Keywords: embryonic structures
sperm injections, intracytoplasmic
IVF
GnRH antagonist
ovarian stimulation
cycle day 2 versus cycle day 5
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Free University Medical Center
First posted: 2009-01-15
Enrollment: 147
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of Top Embryos Per OPU.
timeFrame: 1 year
Secondary outcomes:
measure: Number of Cumulus Oocyte Complexes Obtained
timeFrame: one year
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Bart C Fauser, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hohmann FP, Macklon NS, Fauser BC. A randomized comparison of two ovarian stimulation protocols with gonadotropin-releasing hormone (GnRH) antagonist cotreatment for in vitro fertilization commencing recombinant follicle-stimulating hormone on cycle day 2 or 5 with the standard long GnRH agonist protocol. J Clin Endocrinol Metab. 2003 Jan;88(1):166-73. doi: 10.1210/jc.2002-020788.