HIV and Ovarian Reserve

NCT ID: NCT03572270

Last Updated: 2018-06-28

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2022-11-30

Brief Summary

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Recent evidence suggests a decline in fertility of persons living with HIV (PLWH) (delayed pregnancies, sponteanous abortions, especially when patients receive an antiretroviral therapy, early menopause, amenorrhea and anovulatory cycles) with a possible decrease in ovarian reserve. However, indications of fertility preservation by freezing oocytes are nevertheless not clearly identified.

The objective of this study is to evaluate the ovarian reserve before and after the implementation of antiretroviral treatment in PLWH for whom the diagnosis of HIV has just been made.

Detailed Description

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This is a monocentric prospective cohort study with minimal risk and constraints. Ovarian reserve is compared between two groups: 30 PLWH, at time of diagnosis and 6, 12 and 18 months after initiation of an antiretroviral therapy, and 30 HIV negative women attending medically assisted procreation consultation for male infertility, age, BMI and smoking habits matched.

Conditions

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HIV Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

No masking

Study Groups

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case

PLWH

Group Type EXPERIMENTAL

AMH test

Intervention Type DIAGNOSTIC_TEST

Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve

pelvic ultrasound

Intervention Type DIAGNOSTIC_TEST

Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve

control

HIV negative women, going to medically assisted procreation consultation for male infertility

Group Type OTHER

AMH test

Intervention Type DIAGNOSTIC_TEST

Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve

pelvic ultrasound

Intervention Type DIAGNOSTIC_TEST

Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve

Interventions

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AMH test

Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve

Intervention Type DIAGNOSTIC_TEST

pelvic ultrasound

Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* For every participant :
* woman aged 18 to 37
* covered by social security
* able to give an informed consent

Case group only :

* diagnosis of HIV infection during the 3 months before inclusion
* concomitant initiation of an antiretroviral therapy with integrase inhibitors and nucleoside analogues

Control group only :

* assisting medically assisted procreation consultation for male infertility
* matching case subjects with age, BMI and smoking habits

Exclusion Criteria

* For every participant :
* current pregnancy
* condition or associated treatment that may have an impact on fertility
* premature ovarian failure
* polycystic ovary syndrome
* endometriosis

Control group only :

\- suspected HIV infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florence BRUGNON

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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Chu Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

0473751195

Facility Contacts

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Patrick LACARIN

Role: primary

0473751195

Other Identifiers

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2017-A03469-44

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-391

Identifier Type: -

Identifier Source: org_study_id

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