HIV and Ovarian Reserve

Not Applicable

• Conditions: Infertility; HIV

• Registration Number: NCT03572270
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-05-29
• Status Verified: 2018-06
• Study Start: 2018-06
• Study First Submitted QC: 2018-06-26
• Last Update Submitted: 2018-06-26
• Study First Posted: 2018-06-28
• Last Update Posted: 2018-06-28
• Primary Completion: 2022-06
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change from inclusion visit AMH level at 18 months	M0 (inclusion visit) and M18 (after 18 months)	blood test to evaluate ovarian reserve thanks to AMH

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chu Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France