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

Study Overview
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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.

Official Title
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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?

Conditions
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in Vitro Fertilization, Ovulation Induction

Intervention / Treatment
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* Drug: Mild stimulation


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Start rFSH cycle day 2<br> | Drug: Mild stimulation<br>* Fixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm<br>* Other names: Ganirelix;|
| Experimental: Start rFSH on cycle day 5<br> | Drug: Mild stimulation<br>* Fixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm<br>* Other names: Ganirelix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Top Embryos Per OPU. | Proportion of top embryos per ovum pick-up | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cumulus Oocyte Complexes Obtained | Number of cumulus oocyte complexes obtained after ovum pick-up | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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embryonic structures, sperm injections, intracytoplasmic, IVF, GnRH antagonist, ovarian stimulation, cycle day 2 versus cycle day 5