Endometrial Scratching at Time of Laproscopic Ovarian Drilling in Women With Anovulatory Infertility Due to Polycystic Ovarian Syndrome (PCOS): Randomized Controlled Trial.
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Mansoura University
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- live birth rate per woman randomized
Study Overview
Brief Summary
Laparoscopic Ovarian Drilling is a valid procedure for infertile anovulatory women with polycystic ovarian syndrome who failed to get pregnant or to ovulate with ovulation induction medications as clomiphene citrate or exogenous gonadotropins. The reasearchers supposed that endometrial curettage at time of laparoscopic ovarian drilling may boost fertility in these women.
Detailed Description
Current literature suggests that endometrial biopsy may improve pregnancy rates in infertile women hence the investigators will examine whether this hypothesis will apply to infertile PCOS women undergoing laparoscopic ovarian drilling to overcome ovulatory disfunction or not.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 39 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •subfertile women with anovulatory infertility due to polycystic ovarian syndrome (PCOS).
- •Women who failed to get pregnant after at least 6 months of ovulation induction cycles with clomiphene citrate or exogenous gonadotropins
- •Patent Fallopian tubes as confirmed by hysterosalpingography
- •Fertile semen parameters of the partneraccording to criteria of World Health Organization (WHO 2010).
Exclusion Criteria
- •women with BMI >30,
- •age < 18 years or > 39 years,
- •women with ovarian cysts identified by transvaginal ultrasound
- •male factor infertility
- •Tubal factor infertility as suggested by hystrosalpingogram (HSG)
- •Women with congenital malformations in the uterus as bicornuate or septate uterus as suggested by HSG.
Arms & Interventions
Currettage
Endometrial Currettage (endometrial scrapping) will be performed at the time of laparoscopic ovarian drilling
Intervention: Endometrial Currettage (Procedure)
Nothing
No endometrial curettage at time of Laparoscopic ovarian drilling
Outcomes
Primary Outcomes
live birth rate per woman randomized
Time Frame: 15 months
Secondary Outcomes
- pregnancy rate per woman randomised(6 months)
Investigators
Ahmed Gibreel
Dr
Mansoura University