Subfertility
Conditions
Keywords
Folic Acid, Homocysteine, Ovarian response, In Vitro Fertilization
Brief summary
In vitro fertilization (IVF) is an assisted reproductive technique to achieve pregnancy in subfertile couples of which the average success rate is only 25%. Mild ovarian stimulation treatment yields less oocytes, has less adverse effects but has a comparable clinical outcome compared to conventional stimulation treatment. There is high inter- and intra person variability in ovarian response and fertility outcome parameters after stimulation treatment and little is known about explanatory variables herefore. Nutrition and in particular folate, or its synthetic derivative folic acid, is a B-vitamin which has been widely asssociated with reproductive outcome and subfertility. Therefore, in this study we aim to investigate the influence of preconception nutrition and folic acid use on ovarian response after mild/conventional stimulation treatment and to identify biomarkers in the follicular fluid which can indicate oocyte quality and other fertility outcomes.
Interventions
PROCEDUREMild Ovarian Stimulation Treatment
Administration of a fixed dose of 150 IU/day rFSH s.c. (Puregon® NV Organon, Oss, The Netherlands) from cycle day 5 onwards. As soon as the leading follicle reached a diameter of 14mm, a GnRH-antagonist (Orgalutran®, NV Organon, Oss, The Netherlands) was administered at 0.25 mg/day s.c.. To induce final oocyte maturation a single s.c. dose of 10.000 IE hCG (Pregnyl®, NV Organon. Oss, The Netherlands) was administered.
PROCEDUREConventional Ovarian Stimulation Treatment
Administration of GnRH agonist Triptorelin (Decapeptyl®, Ferring BV, Hoofddorp, The Netherlands) at 0.1 mg/day s.c., starting on cycle day 21 of the menstrual cycle preceding the actual stimulation cycle. After two weeks of the GnRH regimen, co-treatment with rFSH 225 IU/day s.c. (Puregon®, NV Organon, Oss, The Netherlands) was initiated. To induce final oocyte maturation a single s.c. dose of 10.000 IE hCG (Pregnyl®, NV Organon. Oss, The Netherlands) was administered
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 37 Years
Healthy volunteers
No
Inclusion criteria
* All couples with an indication for IVF/ICSI treatment in the Erasmus Medical Center
Exclusion criteria
* Prior oocyte donation * Endometriosis * Hydrosalpinx * MESA/PESA * Age \>37 * BMI \<18 or \>29kg/m2 * Menstrual cycle disruptions * Indication for Intra Cytoplasmic Sperm Injection (ICSI) * Prior IVF treatment without embryo transplant * History of recurrent abortion * Abnormal karyotype of male/female * Uterine abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endocrine, metabolic biomarkers and proteins and Fertility outcome parameters | At menstrual cycle day 2 before stimulation, on the day of hCG administration after stimulation treatment and after embryo transplantation |
Secondary
| Measure | Time frame |
|---|---|
| Homocysteine-methionine cycle biomarker, endocrine and folate levels in serum | At menstrual cycle day 2 before stimulation and on the day of hCG administration after stimulation treatment |
Countries
Netherlands
Outcome results
None listed