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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
History of Changes
  Purpose

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.


Condition Intervention
Subfertility
 Procedure: Mild Ovarian Stimulation Treatment
Procedure: Conventional Ovarian Stimulation Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Food Lifestyle and Fertility Outcome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 54
Study Start Date: October 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 37 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985062

Locations
Netherlands
Erasmus Medical Center
Rotterdam, Zuid-Holland, Netherlands, 3015GD
Sponsors and Collaborators
Erasmus Medical Center
  More Information

Publications:

Responsible Party: Dr. R.P.M. Steegers-Theunissen, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT00985062     History of Changes
Other Study ID Numbers: VPG.03.02
Study First Received: September 24, 2009
Last Updated: September 25, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
Folic Acid
Homocysteine
Ovarian response
In Vitro Fertilization

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 21, 2013