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Endometrial Scratching During Laproscopic Ovarian Drilling in Subfertile PCOS Women (ESLOD)

M

Mansoura University

Status and phase

Unknown
Phase 4

Conditions

Infertility
Polycystic Ovarian Syndrome

Treatments

Procedure: Endometrial Currettage

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

Female

Ages

18 to 39 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. subfertile women with anovulatory infertility due to polycystic ovarian syndrome (PCOS).
  2. Women who failed to get pregnant after at least 6 months of ovulation induction cycles with clomiphene citrate or exogenous gonadotropins
  3. Patent Fallopian tubes as confirmed by hysterosalpingography
  4. Fertile semen parameters of the partneraccording to criteria of World Health Organization (WHO 2010).

Exclusion criteria

  1. women with BMI >30,
  2. age < 18 years or > 39 years,
  3. women with ovarian cysts identified by transvaginal ultrasound
  4. male factor infertility
  5. Tubal factor infertility as suggested by hystrosalpingogram (HSG)
  6. Women with congenital malformations in the uterus as bicornuate or septate uterus as suggested by HSG.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

500 participants in 2 patient groups

Currettage
Experimental group
Description:
Endometrial Currettage (endometrial scrapping) will be performed at the time of laparoscopic ovarian drilling
Treatment:
Procedure: Endometrial Currettage
Nothing
No Intervention group
Description:
No endometrial curettage at time of Laparoscopic ovarian drilling

Trial contacts and locations

1

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Central trial contact

Ahmed Gibreel, MD

Data sourced from clinicaltrials.gov

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