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Completed

NCT Number: NCT00985062

Mild Versus Conventional Ovarian Stimulation Treatment for In Vitro Fertilization

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.

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Key information

Conditions

Subfertility Genital Diseases Infertility Urogenital Diseases

Age range

Up to 37 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mild Ovarian Stimulation Treatment

Procedure

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.

Conventional Ovarian Stimulation Treatment

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

Food Lifestyle and Fertility Outcome

Acronym: FOLFO

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 28, 2009
Registry last updated
Sep 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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