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

UMC Utrecht

Status and phase

Terminated

Phase 4

Conditions

Ovulation Induction

in Vitro Fertilization

Treatments

Drug: Mild stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT00823472

LITE study

CCMO: NL2370504108

METC: 08/233

Details and patient eligibility

About

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.

Enrollment

147 patients

Sex

Female

Ages

18 to 36 years old

Volunteers

Accepts Healthy Volunteers

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)