IVF Versus LOD in Women With CC Resistant PCOS

NCT02456792 | Withdrawn Phase 4

• 1 other identifier: AG1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus laparoscopic ovarian drilling (LOD) in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).

Conditions

Infertility; Polycystic Ovarian Syndrome

Keywords

PCOS; Clomiphene citrate resistant; LOD; IVF

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  Number of live births divided by the number of women

  9 months

Secondary Outcomes (4)

• Clinical pregnancy rate

  6-8 weeks gestational age

• Multifetal pregnancy rate

  12 weeks gestational age

• Miscarriage rate

  12 weeks gestational age

• Incidence of early ovarian hyperstimulation syndrome (OHSS)

  Within 9 days of final triggering of oocyte maturation

Study Arms (2)

IVF group

ACTIVE COMPARATOR

Women will undergo one full IVF cycle

Procedure: IVF

LOD group

ACTIVE COMPARATOR

Women will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months

Procedure: LOD

Interventions

IVF PROCEDURE

Women will undergo one IVF cycle

Also known as: Intracytoplasmic sperm injection (ICSI)

IVF group

LOD PROCEDURE

Women will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months

Also known as: Laparoscopic ovarian diathermy

LOD group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Infertile women with PCOS as defined by the Rotterdam criteria.
• CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).

You may not qualify if:

• Age \< 20 or \> 35 years.
• Presence of any infertility factor other than anovulatory PCOS.
• Previous history of ovarian surgery or surgical removal of one ovary.
• Previous exposure to cytotoxic drugs or pelvic irradiation.
• Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
• Metabolic or hormonal abnormalities.

Sponsors & Collaborators

• Mohamed Sayed Abdelhafez: lead

Study Sites (2)

Fertility Care Unit (FCU) in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

Location

Private fertility care centers

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Conditions

Infertility; Polycystic Ovary Syndrome

Interventions

Sperm Injections, Intracytoplasmic

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

Intervention Hierarchy (Ancestors)

Fertilization in Vitro; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Ahmed Gibreel, Dr

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Mohamed S Abdelhafez, Dr

  Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 23, 2015
• First Posted: May 29, 2015
• Study Start: January 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 10, 2017

Record last verified: 2017-05

Locations

EG (2)