HIV and Ovarian Reserve (VIHRO)

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Infertility; HIV

Treatments: Diagnostic Test: pelvic ultrasound; Diagnostic Test: AMH test

Study type: Interventional

Funder types: Other

Identifiers

NCT03572270

CHU-391

2017-A03469-44 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

case

Experimental group

Description:

PLWH

Treatment:

Diagnostic Test: AMH test

Diagnostic Test: pelvic ultrasound

control

Other group

Description:

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

Treatment:

Diagnostic Test: AMH test

Diagnostic Test: pelvic ultrasound