Fertility

 
 ANTARCTICA 2
 
 SCRaTCH OFO
 ALIFE2
 
 exIUI
 
 FOAM
 
 IVF 38+
 Medium II
 
 SCRaTCH
 
 SelecTIMO
 STIM
 
 T4-LIFE
 TRUST
 
 ZinenZwanger
 PRORAILS
 ALIFE
 Bedrust
 ESEP
 H2Olie
 Freeze-all (progesterone)
 IMPROvEMENT
 INeS
 inSIGHT
 Lifestyle
 MASTER
 > M-ovin"
 OPTIMIST
 Promise
 SUPER

 AID-study
 Antarctica study
 Congeno study
 DESH trial
 ENDO-RECEPT
 Follikel diameter
 IVM study
 L-Age
 Medium
 Metex
 Pr_OVIN
 PRIMA
 SETI
 THL
 

 

M-ovin' study

 

Modified Ovulation Induction.

Treatment alternatives for subfertile women with class II anovulation not conceiving after six ovulatory cycles with clomiphene citrate: A randomized controlled trial.

 

Go to the M-ovin' website.

 

Background

Ovulation induction with Clomiphene citrate (CC) is the first line of treatment in women with WHO class II anovulation. Whereas almost 80% of these patients ovulate after CC, only 40 to 50% conceive. When unsuccessful in conception, treatment can be proceeded with gonadotropins. CC treatment is associated with a 8% risk of multiple gestation, whereas treatment with gonadotropins is associated with a risk of 30-40 %. At present, it is unclear for how many cycles ovulation induction with CC should be repeated, and when to switch to ovulation induction with gonadotropins and/or add of intra-uterine insemination.

 

Objective

The purpose of this study is to assess the effectiveness of extended treatment with CC compared to treatment with gonadotropins and/or the use of intra-uterine insemination (IUI), in patients who had six ovulatory cycles  after CC, but did not conceive. 

 

Study design

A multicenter randomised controlled trial in The Netherlands. 

 

Study population

Subfertile women with WHO class II anovulation who are ovulatory on CC, but have not conceived in 6 ovulatory cycles.

 

Intervention

Patients will be randomly allocated to four treatment arms: extended CC treatment for 6 months, ovulation induction with gonadotropins for 6 months, extended CC treatment with IUI for 6 months and ovulation induction with gonadotropins with IUI for 6 months

 

Main outcome measures

Pregnancy leading to live birth.  

 

Power calculation
The analysis will be by intention to treat. Two comparisons will be made, one in which CC is compared to gonadotropins and one in which the addition of IUI is compared to ovulation induction only. Assuming a live birth rate of 40% after CC, 55% after addition of IUI and 55% after ovulation induction with gonadotrophins, with an alpha of 5% and a power of 80%, we need to recruit 200 women per arm (800 women in total).
An independant Data and Safety Monitoring Committee has critized the data of the first 150 women and concluded that a sample size re-estimation should be performed after including 320 patients (i.e. 80 per arm).




Nature and extent of the burden and risks associated with participation, benefit and group relatedness

As we compare strategies that are already applied in current practice, no additional risks or burdens are expected from the study.

 

Subsidy

ZonMw

 

Contact

N.Weiss: m-ovin@studies-obsgyn.nl