LOD Before IVF/ICSI in PCOS Patients With High AMH

Laparoscopic Ovarian Drilling Before IVF/ICSI in Polycystic Ovarian Syndrome Patients With High Antimullarian Hormone

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

Study Overview

• Status: Completed
• Conditions: Infertility; Polycystic Ovarian Syndrome
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansourah, Dakahlia, Egypt, 35111
      • Fertility Care Unit (FCU) in Mansoura University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Fertility care clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of oocytes retrieved	Number of collected oocytes during oocyte retrieval	36-38 hours after triggering of oocyte maturation
Oocyte maturity rate	Calculated for each woman by dividing the number of mature oocytes (MII oocytes) by the total number of oocytes retrieved	Within one hour after oocyte retrieval
Fertilization rate	Calculated for each couple by dividing the number of fertilized oocytes by the number of injected (or inseminated) oocytes	20-24 hours after injection (or insemination)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate	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	6 weeks after embryo transfer
Implantation rate	Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos	6 weeks after embryo transfer
Incidence of early OHSS	Incidence of OHSS within 9 days of final triggering of oocyte maturation	Within 9 days of final triggering of oocyte maturation

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Alaa Wageh, Dr, Mansoura University; Study Director: Maher Shams, Dr, Mansoura University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 22, 2013
• Primary Completion (ACTUAL): May 31, 2017
• Study Completion (ACTUAL): June 18, 2017

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (ACTUAL): November 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: PCOS; AMH; OHSS; LOD
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome; Infertility
• Other Study ID Numbers: MSA6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No