Mild Versus Conventional Ovarian Stimulation Treatment for In Vitro Fertilization (FOLFO)
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.
|Subfertility||Procedure: Mild Ovarian Stimulation Treatment Procedure: Conventional Ovarian Stimulation Treatment|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Food Lifestyle and Fertility Outcome|
- Endocrine, metabolic biomarkers and proteins and Fertility outcome parameters [ Time Frame: At menstrual cycle day 2 before stimulation, on the day of hCG administration after stimulation treatment and after embryo transplantation ]
- Homocysteine-methionine cycle biomarker, endocrine and folate levels in serum [ Time Frame: At menstrual cycle day 2 before stimulation and on the day of hCG administration after stimulation treatment ]
|Study Start Date:||October 2004|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
|Active Comparator: Mild Ovarian Stimulation||
Procedure: Mild 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.
|Active Comparator: Conventional Ovarian Stimulation||
Procedure: Conventional 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985062
|Erasmus Medical Center|
|Rotterdam, Zuid-Holland, Netherlands, 3015GD|