At a glance

ClinicalIndex Comparison Record

N/ACompleted· 54 enrolled

Drug / intervention

Mild Ovarian Stimulation Treatment +1 moreprocedure

Likely dose

Not stated in record

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Search/NCT00985062

NCT00985062N/ACompleted

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Food Lifestyle and Fertility Outcome

Erasmus Medical Center·interventional·Posted Sep 28, 2009·Updated Sep 28, 2009

In Brief

A clinical study evaluating Mild Ovarian Stimulation Treatment and Conventional Ovarian Stimulation Treatment for Subfertility. Completed, enrolled 54 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSubfertility

CountriesNetherlands

Collaborators--

Timeline

N/ACompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartOct 2004

Primary CompletionDec 2006

First PostedSep 2009

TodayJul 2026

First PostedSep 28, 2009

Enrollment StartOct 1, 2004

Primary CompletionDec 1, 2006

TodayJul 2, 2026

Enrollment to primary: 2.2 yearsPosted 16.8 years ago

Interventions

Mild Ovarian Stimulation Treatmentprocedure

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 Treatmentprocedure

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