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Completed

NCT Number: NCT02210013

Differences in Ovarian Aging 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.

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Key information

Conditions

Age of the Patients and the Body Mass Index in Both Groups

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. AMH levels produced by granulosa cells

    Time frame: day 1

    AMH levels (ng/mL) as well as AFC in both ethnic groups.

Secondary outcomes

  1. Number of oocytes

    Time frame: day 1

    The number of oocytes retrieved as well as the mature oocytes after IVF ovarian stimulation

Sponsors and collaborators

Lead sponsor

IVI Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Aug 6, 2014
Registry last updated
Aug 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.