HIV and Ovarian Reserve (VIHRO)

Evaluation of the Potential Impact of HIV and Its Treatments on Ovarian Reserve: Prospective Study

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.

Study Overview

• Status: Unknown
• Conditions: Infertility; HIV
• Intervention / Treatment: Diagnostic test: AMH test; Diagnostic test: pelvic ultrasound

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 37 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: case; PLWH	Diagnostic test: AMH test; Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve; Diagnostic test: pelvic ultrasound; Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve
OTHER: control; HIV negative women, going to medically assisted procreation consultation for male infertility	Diagnostic test: AMH test; Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve; Diagnostic test: pelvic ultrasound; Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from inclusion visit AMH level at 18 months	blood test to evaluate ovarian reserve thanks to AMH	M0 (inclusion visit) and M18 (after 18 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
antral follicle count	pelvic ultrasound to evaluate ovarian reserve thanks to antral follicle count	Month 0 (inclusion visit), Month 6 (after 6 months), Month12 (after one year), Month18 (after 18 months)
estradiol, lutenizing hormone and follicle-stimulating hormone test	blood test	Month 0 (inclusion visit), Month 6 (after 6 months), Month 12 (after one year), Month18 (after 18 months)

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2018
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): November 1, 2022

Study Registration Dates

• First Submitted: May 29, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (ACTUAL): June 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2018
• Last Update Submitted That Met QC Criteria: June 26, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: HIV; Fertility preservation; Ovarian reserve; Anti HIV agents
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: CHU-391; 2017-A03469-44 (OTHER: 2017-A03469-44)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No