Mild Versus Conventional Ovarian Stimulation Treatment for In Vitro Fertilization (FOLFO)

This study has been completed.
Sponsor:
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00985062
First received: September 24, 2009
Last updated: September 25, 2009
Last verified: September 2009

September 24, 2009
September 25, 2009
October 2004
December 2006   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00985062 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Mild Versus Conventional Ovarian Stimulation Treatment for In Vitro Fertilization
Food Lifestyle and Fertility Outcome

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Subfertility
  • 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.
  • 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
  • Active Comparator: Mild Ovarian Stimulation
    Intervention: Procedure: Mild Ovarian Stimulation Treatment
  • Active Comparator: Conventional Ovarian Stimulation
    Intervention: Procedure: Conventional Ovarian Stimulation Treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Both
up to 37 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00985062
VPG.03.02
Yes
Dr. R.P.M. Steegers-Theunissen, Erasmus Medical Center
Erasmus Medical Center
Not Provided
Not Provided
Erasmus Medical Center
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP