LOD Before IVF/ICSI in PCOS Patients With High AMH

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT03358199

Collaborator

(none)

120

Enrollment

Location

50.9

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

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 :

Mar 22, 2013

Actual Primary Completion Date :

May 31, 2017

Actual Study Completion Date :

Jun 18, 2017

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)