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Mild Versus Conventional Ovarian Stimulation Treatment for In Vitro Fertilization

NCT00985062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2009-09-28

No results posted yet for this study

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.

Conditions

  • Subfertility

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
37 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00985062 on ClinicalTrials.gov