HIV and Ovarian Reserve

HIV Clinical Trial

— VIHRO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03572270
• Other study ID #: CHU-391
• Secondary ID: 2017-A03469-44
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2018
• Est. completion date: November 2022

Study information

• Verified date: June 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 0473751195
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Infertility

Intervention

Diagnostic Test:
• AMH test
Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve
• pelvic ultrasound
Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve

Locations

Country	Name	City	State
France	Chu Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)