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LOD Before IVF/ICSI in PCOS Patients With High AMH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03358199
Recruitment Status : Completed
First Posted : November 30, 2017
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Sayed Abdelhafez, Mansoura University

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment
Infertility Polycystic Ovarian Syndrome Procedure: LOD

Detailed Description:
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)
Study Design
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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Laparoscopic Ovarian Drilling Before IVF/ICSI in Polycystic Ovarian Syndrome Patients With High Antimullarian Hormone
Actual Study Start Date : March 22, 2013
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : June 18, 2017

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Study group
PCOS women with AMH level (≥ 7 ng/ml) who underwent LOD in the preceding 3 months prior to IVF/ICSI
 Procedure: LOD
Women underwent LOD in the preceding 3 months prior to IVF/ICSI
Other Name: Laparoscopic ovarian drilling
Control group
PCOS women with AMH level (≥ 7 ng/ml) who did not undergo LOD in the preceding 3 months prior to IVF/ICSI


Outcome Measures
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Primary Outcome Measures :
  1. Number of oocytes retrieved [ Time Frame: 36-38 hours after triggering of oocyte maturation ]
    Number of collected oocytes during oocyte retrieval

  2. Oocyte maturity rate [ Time Frame: Within one hour after oocyte retrieval ]
    Calculated for each woman by dividing the number of mature oocytes (MII oocytes) by the total number of oocytes retrieved

  3. Fertilization rate [ Time Frame: 20-24 hours after injection (or insemination) ]
    Calculated for each couple by dividing the number of fertilized oocytes by the number of injected (or inseminated) oocytes


Secondary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 6 weeks after embryo transfer ]
    Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures

  2. Implantation rate [ Time Frame: 6 weeks after embryo transfer ]
    Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos

  3. Incidence of early OHSS [ Time Frame: Within 9 days of final triggering of oocyte maturation ]
    Incidence of OHSS within 9 days of final triggering of oocyte maturation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Fertility care clinic
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358199


Locations
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Egypt
Fertility Care Unit (FCU) in Mansoura University Hospital
Mansourah, Dakahlia, Egypt, 35111
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Mohamed S Abdelhafez, Dr Mansoura University
Study Director: Alaa Wageh, Dr Mansoura University
Study Director: Waleed El-refaie, Dr Mansoura University
Study Director: Maher Shams, Dr Mansoura University
More Information
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Responsible Party: Mohamed Sayed Abdelhafez, Principal Investigator, Mansoura University
ClinicalTrials.gov Identifier: NCT03358199    
Other Study ID Numbers: MSA6
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Sayed Abdelhafez, Mansoura University:
LOD
PCOS
AMH
OHSS
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Infertility
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
 Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases