"Stair Step Study"

• Status: Completed
• Trial end date: 2018-05-31
• Target enrollment: 0
• Participant gender: Female

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 and live birth rate.

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

Study population:

Women with oligomenorrhea or amenorrhea according to WHO classification category 2

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.

Main study parameters/endpoints:

The primary endpoints are the time to pregnancy and ongoing pregnancy rate within a treatment horizon of 3 cycles. Secondary endpoints include time to ovulation, endometrial thickness, multiple pregnancy and the incidence of treatment failure.

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

The number of site visits or physical examinations will not differ from accepted clinical practice.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Radboud University
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Medroxyprogesterone; Medroxyprogesterone Acetate; Zuclomiphene

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 < 40 kg/m2

Exclusion Criteria:

• 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