Age of the Patients and the Body Mass Index in Both GroupsNCT02210013

Differences in Ovarian Aging Between Caucasian and Indian Women

An observational study of Age of the Patients and the Body Mass Index in Both Groups, run by IVI Madrid.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 42 years, women only
Conditions the study is for: Age of the Patients and the Body Mass Index in Both Groups
How many people: 400 participants
Where: No sites listed yet
Study dates: Jan 2012to Jan 2013
How long will I take part?: 11 Months
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 42 years
Women only
No healthy volunteers
Adult

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.

Who may be able to join

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).

Who cannot join

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

About this study

Official title: 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.

Read the 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.

Conditions: Age of the Patients and the Body Mass Index in Both Groups
Keywords: AMH, AFC, aging, ethnicity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02210013
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

AMH levels produced by granulosa cells
AMH levels (ng/mL) as well as AFC in both ethnic groups.
Measured: day 1

Secondary outcomes (1)

Number of oocytes
The number of oocytes retrieved as well as the mature oocytes after IVF ovarian stimulation
Measured: day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jan 2013

First posted6 Aug 2014 (estimated)
Study startJan 2012
Primary completionDec 2012
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Age of the Patients and the Body Mass Index in Both GroupsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 400 participants (actual)
Target duration: 11 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT02210013
Sponsor's protocol ID: MAD-CI-01-2012-01
Status last verified: Aug 2014
First submitted: 29 Jul 2014
Last updated: 6 Aug 2014
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ethnicity as a Determinant of Ovarian Aging: Differences Between Caucasian and Indian Women
ClinicalTrials.gov ID: NCT02210013
Acronym / sponsor ID: MAD-CI-01-2012-01
Conditions: Age of the Patients and the Body Mass Index in Both Groups
Keywords: AMH, AFC, aging, ethnicity
Study type: Observational
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: IVI MadridUniversity, hospital or other
Study start: Jan 2012
Primary completion: Dec 2012 (actual)
Study completion: Jan 2013 (actual)
First posted: 6 Aug 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 11 Months
Number of arms: 2

Arm	Type	Receives
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.

Who may qualify

Ages: 18 to 42 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult
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.

Key inclusion criteria (1 listed)

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).

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

AMH levels produced by granulosa cells
Time frame: day 1
AMH levels (ng/mL) as well as AFC in both ethnic groups.

1 secondary outcome

Number of oocytes
Time frame: day 1

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carlos Iglesias, M.D. principal investigator

IVI Madrid

Manish Banker, M.D. principal investigator

NOVA IVI

Nalini Mahajan, M.D. principal investigator

NOVA IVI

Questions about this trial

What is this clinical trial studying?

An observational study of Age of the Patients and the Body Mass Index in Both Groups, run by IVI Madrid.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AMH levels produced by granulosa cells (time frame: day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02210013.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.