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Is endometrial withdrawal bleeding necessary prior to ovulation induction with clomiphene citrate?;A randomized controlled trial and feasibility study

Is endometrial withdrawal bleeding necessary prior to ovulation induction with clomiphene citrate?;A randomized controlled trial and feasibility study - Stair Step Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43480
Enrollment
42
Registered
2016-04-29
Start date
2016-06-21
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS/non-PCOS WHO 2 ovulation disorders

Interventions

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 c
a progesterone induced withdrawal bleeding in case of no spontaneous menses before starting an ovulation induction cycle and in between anovulatory cycles.

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: BMI > 40 kg/m2 Previous unsuccessful ovulation induction cycles with clomiphene citrate Double-sided tubal pathology Moderate - severe male infertility (TMSC

Design outcomes

Primary

MeasureTime frame
The primary endpoints are the time to pregnancy and ongoing pregnancy rate within a treatment horizon of 3 cycles.

Secondary

MeasureTime frame
Secondary endpoints include time to ovulation, endometrial thickness, multiple pregnancy and the incidence of treatment failure.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)