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

Phase 4

Terminated

• Conditions: in Vitro Fertilization; Ovulation Induction
• Interventions: Drug: Mild stimulation

• Registration Number: NCT00823472
• Lead Sponsor: UMC Utrecht

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-13
• Study First Posted: 2009-01-15
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2010-11-02
• Results First Submitted QC: 2010-11-02
• Results First Posted: 2010-12-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 147

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Start rFSH cycle day 2	Mild stimulation	-
Start rFSH on cycle day 5	Mild stimulation	-

Primary Outcome Measures

Name	Time	Method
Proportion of Top Embryos Per OPU.	1 year	Proportion of top embryos per ovum pick-up

Secondary Outcome Measures

Name	Time	Method
Number of Cumulus Oocyte Complexes Obtained	one year	Number of cumulus oocyte complexes obtained after ovum pick-up

Trial Locations

Locations (2)

UZ Brussel; 🇧🇪 Brussel, Belgium

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands