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Mild Versus Conventional Ovarian Stimulation Treatment for In Vitro Fertilization (FOLFO)

Erasmus University logo

Erasmus University

Status

Completed

Conditions

Subfertility

Treatments

Procedure: Conventional Ovarian Stimulation Treatment
Procedure: Mild Ovarian Stimulation Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT00985062
VPG.03.02

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

Under 37 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 2 patient groups

Mild Ovarian Stimulation
Active Comparator group
Treatment:
Procedure: Mild Ovarian Stimulation Treatment
Conventional Ovarian Stimulation
Active Comparator group
Treatment:
Procedure: Conventional Ovarian Stimulation Treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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