IVF Versus LOD in Women With CC Resistant PCOS

NCT ID: NCT02456792

Last Updated: 2017-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-05-31

Brief Summary

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The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus laparoscopic ovarian drilling (LOD) in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).

Detailed Description

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Women will be randomly divided into two groups; IVF group and LOD group. Women in the IVF group will undergo one full IVF cycle. Women in the LOD group will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months.

Conditions

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Infertility Polycystic Ovarian Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IVF group

Women will undergo one full IVF cycle

Group Type ACTIVE_COMPARATOR

IVF

Intervention Type PROCEDURE

Women will undergo one IVF cycle

LOD group

Women will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months

Group Type ACTIVE_COMPARATOR

LOD

Intervention Type PROCEDURE

Women will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months

Interventions

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IVF

Women will undergo one IVF cycle

Intervention Type PROCEDURE

LOD

Women will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months

Intervention Type PROCEDURE

Other Intervention Names

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Intracytoplasmic sperm injection (ICSI) Laparoscopic ovarian diathermy

Eligibility Criteria

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Inclusion Criteria

* Infertile women with PCOS as defined by the Rotterdam criteria.
* CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).

Exclusion Criteria

* Age \< 20 or \> 35 years.
* Presence of any infertility factor other than anovulatory PCOS.
* Previous history of ovarian surgery or surgical removal of one ovary.
* Previous exposure to cytotoxic drugs or pelvic irradiation.
* Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
* Metabolic or hormonal abnormalities.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mohamed Sayed Abdelhafez

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Sayed Abdelhafez

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmed Gibreel, Dr

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Mohamed S Abdelhafez, Dr

Role: STUDY_DIRECTOR

Mansoura University

Locations

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Fertility Care Unit (FCU) in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Private fertility care centers

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AG1

Identifier Type: -

Identifier Source: org_study_id

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