LOD Before IVF/ICSI in PCOS Patients With High AMH

NCT03358199 | Completed

• 1 other identifier: MSA6
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility; Polycystic Ovarian Syndrome

Keywords

LOD; PCOS; AMH; OHSS

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Clinical pregnancy rate

  6 weeks after embryo transfer

• Implantation rate

  6 weeks after embryo transfer

• Incidence of early OHSS

  Within 9 days of final triggering of oocyte maturation

Study Arms (2)

Study group

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

Procedure: LOD

Control group

PCOS women with AMH level (≥ 7 ng/ml) who did not undergo LOD in the preceding 3 months prior to IVF/ICSI

Interventions

LOD PROCEDURE

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

Also known as: Laparoscopic ovarian drilling

Study group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Fertility care clinic

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Fertility Care Unit (FCU) in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

Location

MeSH Terms

Conditions

Infertility; Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Mohamed S Abdelhafez, Dr

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Alaa Wageh, Dr

  Mansoura University

  STUDY DIRECTOR

• Waleed El-refaie, Dr

  Mansoura University

  STUDY DIRECTOR

• Maher Shams, Dr

  Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: November 30, 2017
• Study Start: March 22, 2013
• Primary Completion: May 31, 2017
• Study Completion: June 18, 2017
• Last Updated: December 2, 2017

Record last verified: 2017-11

Locations

EG (1)