LOD Before IVF/ICSI in PCOS Patients With High AMH

NCT ID: NCT03358199

Last Updated: 2017-12-02

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

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-22

Study Completion Date

2017-06-18

Brief Summary

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To evaluate the effect of performing laparoscopic ovarian drilling (LOD) before proceeding to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) on the cycle outcomes in polycystic ovarian syndrome (PCOS) patients with high antimullerian hormone (AMH) levels

Detailed Description

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Retrospective case-control study of PCOS women with high serum AMH level (≥ 7 ng/ml) who were subjected IVF/ICSI. Women underwent LOD in the preceding 3 months prior to IVF/ICSI (study group) will be compared with a control group of women who did not underwent LOD (control group)

Conditions

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Infertility Polycystic Ovarian Syndrome

Keywords

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LOD PCOS AMH OHSS

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Study group

PCOS women with AMH level (≥ 7 ng/ml) who underwent LOD in the preceding 3 months prior to IVF/ICSI

LOD

Intervention Type PROCEDURE

Women underwent LOD in the preceding 3 months prior to IVF/ICSI

Control group

PCOS women with AMH level (≥ 7 ng/ml) who did not undergo LOD in the preceding 3 months prior to IVF/ICSI

No interventions assigned to this group

Interventions

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LOD

Women underwent LOD in the preceding 3 months prior to IVF/ICSI

Intervention Type PROCEDURE

Other Intervention Names

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Laparoscopic ovarian drilling

Eligibility Criteria

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Inclusion Criteria

* PCOS women subjected to COS through fixed gonadotropin releasing hormone (GnRH) antagonist protocol with final triggering of oocyte maturation by GnRH agonist (GnRHa)
* Elevated serum AMH level (≥ 7 ng/ml)

Exclusion Criteria

* Age \< 18 years or \> 35 years
* Body mass index (BMI) \< 19 kg/m2 or \> 35 kg/m2
* Use of cabergoline therapy or coasting to minimize the risk of OHSS
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Sayed Abdelhafez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed S Abdelhafez, Dr

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Alaa Wageh, Dr

Role: STUDY_DIRECTOR

Mansoura University

Waleed El-refaie, Dr

Role: STUDY_DIRECTOR

Mansoura University

Maher Shams, 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

Countries

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Egypt

Other Identifiers

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MSA6

Identifier Type: -

Identifier Source: org_study_id