Differences in Ovarian Aging Between Caucasian and Indian Women

NCT ID: NCT02210013

Last Updated: 2014-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Caucasian women

200 Caucasian infertile women undergoing their first or second IVF cycle

No interventions assigned to this group

Indian women

200 Indian women undergoing their first or second IVF cycle.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IVI Madrid

OTHER

Sponsor Role lead

Responsible Party

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Juan A Garcia-Velasco

Juan A Garcia-Velasco, MD, Phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos Iglesias, M.D.

Role: PRINCIPAL_INVESTIGATOR

IVI Madrid

Manish Banker, M.D.

Role: PRINCIPAL_INVESTIGATOR

NOVA IVI

Nalini Mahajan, M.D.

Role: PRINCIPAL_INVESTIGATOR

NOVA IVI

Leyre Herrero, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

IVI Madrid

Antonio Pellicer, M.D.

Role: PRINCIPAL_INVESTIGATOR

IVI VALENCIA

Juan Antonio Garcia-Velasco, M.D.

Role: PRINCIPAL_INVESTIGATOR

IVI Madrid

Other Identifiers

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MAD-CI-01-2012-01

Identifier Type: -

Identifier Source: org_study_id

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