To evaluate the effects of withholding progesterone-induced endometrial withdrawal bleeding before ovulation induction on the time to pregnancy and the ongoing pregnancy rate.
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are the time to pregnancy and ongoing pregnancy rate
within a treatment horizon of 3 cycles.
Secondary outcome
Secondary endpoints include time to ovulation, endometrial thickness, multiple
pregnancy and the incidence of treatment failure.
Background summary
There is some information suggesting that a progesterone-induced withdrawal
bleeding before the start of ovulation induction in women suffering from oligo-
or amenorrhea reduces pregnancy and live birth rate.
Study objective
To evaluate the effects of withholding progesterone-induced endometrial
withdrawal bleeding before ovulation induction on the time to pregnancy and the
ongoing pregnancy rate.
Study design
Prospective multicenter randomized controlled feasibility study
Intervention
Patients will be randomized to receive one of the following two treatments:
Stair step group: blind start ovulation induction (no progesterone induced
withdrawal bleeding and stair step protocol in case of treatment failure.
Control: standard care; a progesterone induced withdrawal bleeding in case of
no spontaneous menses before starting an ovulation induction cycle and in
between anovulatory cycles.
Study burden and risks
The number of site visits or physical examinations will not differ from
accepted clinical practice.
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
WHO classification category 2 PCOS or non-PCOS
Age between 18 - 41 years
Patent Fallopian tubes, proven by hysterosalpingography (HSG), a negative Chlamydia antibody titre (CAT) or diagnostic laparoscopy combined with tubal testing (DLS and TT), depending on the local protocol.
BMI < 40 kg/m2
Exclusion criteria
BMI > 40 kg/m2
Previous unsuccessful ovulation induction cycles with clomiphene citrate
Double-sided tubal pathology
Moderate - severe male infertility (TMSC < 3 million)
Grade III/IV endometriosis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56254.091.15 |