Differences in Ovarian Aging Between Caucasian and Indian Women

Ethnicity as a Determinant of Ovarian Aging: Differences Between Caucasian and Indian Women

The investigators want to carry out a prospective study of 400 infertile Caucasian and Indian women who will undergo a controlled ovarian stimulation for in vitro fertilization (IVF). The investigators will collect data about ovarian reserve markers and also the results after ovarian stimulation in both ethnic groups.The aim is to identify differences in ovarian response after IVF stimulation between both groups.

Study Overview

• Status: Completed
• Conditions: Age of the Patients and the Body Mass Index in Both Groups

Detailed Description

A total of 200 Caucasian patients and 200 Indian patients who will attend the first or second IVF cycle will be included.

The date we will collect in both groups include the age, the body mass index, and the ovarian reserve markers like the antral follicle count (AFC), the follicle stimulation hormone (FSH) and antimullerian hormone (AMH) serum levels.

The investigators will also determine the number of oocytes retrieved and the metaphase two oocytes in both groups after IVF stimulation.

• Study Type: Observational
• Enrollment (Actual): 400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Caucasian infertile women and Indican infertile women age < 42 years old, with both ovaries present, undergoing an IVF treatment due to male factor, tubal disease or previous failed IUI.

Description

Inclusion Criteria:

• Women aged < 42 years old, with both ovaries present, undergoing a first or second IVF treatment due to male factor, tubal disease or previous failed intrauterine insemination (IUI).

Exclusion Criteria:

• Women diagnosed of polycystic ovary syndrome according to Rotterdam criteria, endometriosis stage III-IV, or previous pelvic inflammatory disease.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Caucasian women; 200 Caucasian infertile women undergoing their first or second IVF cycle
Indian women; 200 Indian women undergoing their first or second IVF cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AMH levels produced by granulosa cells	AMH levels (ng/mL) as well as AFC in both ethnic groups.	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of oocytes	The number of oocytes retrieved as well as the mature oocytes after IVF ovarian stimulation	day 1

Collaborators and Investigators

• Sponsor: IVI Madrid
• Investigators: Principal Investigator: Carlos Iglesias, M.D., IVI Madrid; Principal Investigator: Manish Banker, M.D., NOVA IVI; Principal Investigator: Nalini Mahajan, M.D., NOVA IVI; Principal Investigator: Leyre Herrero, Ph. D., IVI Madrid; Principal Investigator: Antonio Pellicer, M.D., IVI Valencia; Principal Investigator: Juan Antonio Garcia-Velasco, M.D., IVI Madrid

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 6, 2014

Study Record Updates

• Last Update Posted (Estimate): August 6, 2014
• Last Update Submitted That Met QC Criteria: August 5, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: AMH, AFC, aging, ethnicity
• Other Study ID Numbers: MAD-CI-01-2012-01