LOD Before IVF/ICSI in PCOS Patients With High AMH

Completed

• Conditions: Polycystic Ovarian Syndrome; Infertility
• Interventions: Procedure: LOD

• Registration Number: NCT03358199
• Lead Sponsor: Mansoura University

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

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 Timeline

• Study Start: 2013-03-22
• Primary Completion: 2017-05-31
• Study Completion: 2017-06-18
• Status Verified: 2017-11
• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-11-27
• Last Update Submitted: 2017-11-29
• Study First Posted: 2017-11-30
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of oocytes retrieved	36-38 hours after triggering of oocyte maturation	Number of collected oocytes during oocyte retrieval
Oocyte maturity rate	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
Fertilization rate	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

Name	Time	Method
Clinical pregnancy rate	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
Implantation rate	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
Incidence of early OHSS	Within 9 days of final triggering of oocyte maturation	Incidence of OHSS within 9 days of final triggering of oocyte maturation

Trial Locations

Locations (1)

Fertility Care Unit (FCU) in Mansoura University Hospital; 🇪🇬 Mansourah, Dakahlia, Egypt