Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome (OSIPS)

Mansoura University

Status and phase: Completed; Phase 4

Conditions: Intrauterine Insemination; Infertility; Polycystic Ovarian Syndrome

Treatments: Procedure: Intrauterine insemination (IUI)

Study type: Interventional

Funder types: Other

Identifiers

NCT01675843

AG/4/2010

Details and patient eligibility

About

The study null hypothethesis is: intrauterine insemination (IUI) does not improve pregnancy rates in women with polycystic ovary syndrome. Infertile women with pcos will receive gonadotropins for ovarian stimulation and then randomize to either IUI or timed intercourse (TI)

Enrollment: 140 patients

Sex: Female

Ages: 21 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women who failed to get pregnant after 6 ovulation induction cycles with clomiphene citrate (cc) alone, despite of being ovulating with cc, having patent Fallopian tubes as confirmed by hysterosalpingography and their partners had fertile semen parameters according to criteria of World Health Organization (WHO 2010)

Exclusion criteria

male factor infertility

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Group A

Experimental group

Description:

controlled ovarian hyperstimulation (COH) and intrauterine insemination (IUI)

Treatment:

Procedure: Intrauterine insemination (IUI)

Group B

No Intervention group

Description:

Controlled ovarian hyperstimulation (COH)+ Timed Intercourse (TI)