HIV and Ovarian Reserve

Study Overview
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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.

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

Conditions
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HIV, Infertility

Intervention / Treatment
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* Diagnostic Test: AMH test
* Diagnostic Test: pelvic ultrasound


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: case<br>PLWH | Diagnostic Test: AMH test<br>* Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve<br>Diagnostic Test: pelvic ultrasound<br>* Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve<br>|
| Other: control<br>HIV negative women, going to medically assisted procreation consultation for male infertility | Diagnostic Test: AMH test<br>* Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve<br>Diagnostic Test: pelvic ultrasound<br>* Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Anti HIV agents, Ovarian reserve, Fertility preservation