LOD Before IVF/ICSI in PCOS Patients With High AMH

Study Overview
=================
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)

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

Conditions
-----------------
Infertility, Polycystic Ovarian Syndrome

Intervention / Treatment
-----------------
* Procedure: LOD


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>PCOS women with AMH level (≥ 7 ng/ml) who underwent LOD in the preceding 3 months prior to IVF/ICSI | Procedure: LOD<br>* Women underwent LOD in the preceding 3 months prior to IVF/ICSI<br>* Other names: Laparoscopic ovarian drilling;|
| Control group<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LOD, PCOS, AMH, OHSS