Status:
COMPLETED
"Stair Step Study"
Lead Sponsor:
Radboud University Medical Center
Conditions:
Ovulation Disorder
Eligibility:
FEMALE
18-41 years
Phase:
PHASE4
Brief Summary
Rationale: 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 ...
Detailed Description
OBJECTIVES Primary objective: To demonstrate whether withholding progesterone induced endometrial shedding prior to ovulation induction improves the ongoing pregnancy rate per cycle compared to not ...
Eligibility Criteria
Inclusion
- 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
- BMI \> 40 kg/m2
- Previous unsuccessful ovulation induction cycles with CC
- Double-sided tubal pathology
- Presence of ovarian cysts on ultrasound
- Moderate - severe male infertility (TMSC \< 3 million)
- Grade III/IV endometriosis
- Thrombosis
- Severe liver disease
Key Trial Info
Start Date :
June 21 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2018
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03309176
Start Date
June 21 2016
End Date
May 31 2018
Last Update
June 6 2018
Active Locations (3)
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1
Gelderse Vallei Hospital
Ede, Gelderland, Netherlands
2
Canisius-Wilhelmina Hospital
Nijmegen, Gelderland, Netherlands
3
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands