LOD Before IVF/ICSI in PCOS Patients With High AMH

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03358199
• Other study ID #: MSA6
• Status: Completed
• Phase: N/A
• First received: November 27, 2017
• Last updated: November 29, 2017
• Start date: March 22, 2013
• Est. completion date: June 18, 2017

Study information

• Verified date: November 2017
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 18, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Procedure:
• LOD
Women underwent LOD in the preceding 3 months prior to IVF/ICSI

Locations

Country	Name	City	State
Egypt	Fertility Care Unit (FCU) in Mansoura University Hospital	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes retrieved	Number of collected oocytes during oocyte retrieval	36-38 hours after triggering of oocyte maturation
Primary	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
Primary	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	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
Secondary	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
Secondary	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