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HIV and Ovarian Reserve

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03572270
Acronym
VIHRO
Enrollment
60
Registered
2018-06-28
Start date
2018-06-30
Completion date
2022-11-30
Last updated
2018-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Infertility

Keywords

HIV, Ovarian reserve, Fertility preservation, Anti HIV agents

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.

Interventions

DIAGNOSTIC_TESTAMH test

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

DIAGNOSTIC_TESTpelvic ultrasound

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

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

No masking

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
change from inclusion visit AMH level at 18 monthsM0 (inclusion visit) and M18 (after 18 months)blood test to evaluate ovarian reserve thanks to AMH

Secondary

MeasureTime frameDescription
antral follicle countMonth 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
estradiol, lutenizing hormone and follicle-stimulating hormone testMonth 0 (inclusion visit), Month 6 (after 6 months), Month 12 (after one year), Month18 (after 18 months)blood test

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr0473751195

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026