Mild Versus Conventional Ovarian Stimulation Treatment for In Vitro Fertilization

Not Applicable

Completed

• Conditions: Subfertility
• Interventions: Procedure: Mild Ovarian Stimulation Treatment; Procedure: Conventional Ovarian Stimulation Treatment

• Registration Number: NCT00985062
• Lead Sponsor: Erasmus Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2009-09
• Study First Submitted: 2009-09-24
• Study First Submitted QC: 2009-09-25
• Last Update Submitted: 2009-09-25
• Study First Posted: 2009-09-28
• Last Update Posted: 2009-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild Ovarian Stimulation	Mild Ovarian Stimulation Treatment	-
Conventional Ovarian Stimulation	Conventional Ovarian Stimulation Treatment	-

Primary Outcome Measures

Name	Time	Method
Endocrine, metabolic biomarkers and proteins and Fertility outcome parameters	At menstrual cycle day 2 before stimulation, on the day of hCG administration after stimulation treatment and after embryo transplantation

Secondary Outcome Measures

Name	Time	Method
Homocysteine-methionine cycle biomarker, endocrine and folate levels in serum	At menstrual cycle day 2 before stimulation and on the day of hCG administration after stimulation treatment

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands