A multicentre randomised controlled trial comparing in vitro maturation of oocytes with in vitro fertilisation in women with an increased risk of ovarian hyperstimulation syndrome.

Completed

• Conditions: Infertility; Polycystic Ovarian Syndrome (PCOS); Ovarian Hyperstimulation Syndrome (OHSS); Pregnancy and Childbirth; Procreative management

• Registration Number: ISRCTN61229302
• Lead Sponsor: Jeroen Bosch Hospital (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

1. Women with Polycystic Ovarian Syndrome (PCOS) according to the Rotterdam Criteria (The Rotterdam
European Society of Human Reproduction and Embryology [ESHRE] /American Society for Reproductive Medicine [ASRM] - Sponsored PCOS consensus workshop group, 2004) which not did achieve an ongoing pregnancy after ovulation induction (with clomiphene citrate or Laparoscopic Electrocoagulation of the Ovaries (LEO) and Recombinant Follicle Stimulating Hormone [rFSH])
2. Women with an IVF or ICSI indication and increased risk for developing Ovarian Hyperstimulation Syndrome (OHSS) (history of OHSS or cycle cancellation for imminent OHSS)

Exclusion Criteria

1. Woman or partner younger than 18 years and woman older than 38 years
2. Unable to speak or read the Dutch language
3. Medical contraindication for pregnancy or childbirth
4. Positive serology for Hepatitis B, C or HIV
5. Diminished ovarian reserve: early follicular serum FSH > 10 IU/l and/or poor response during earlier COH/IVF or COH/ICSI with = 150 IU rFSH/day
6. Persisting ovarian cysts > 30 mm diameter

Study & Design

• Study Type: Interventional
• Study Design: Not specified