HIV and Ovarian Reserve
VIHRO
Evaluation of the Potential Impact of HIV and Its Treatments on Ovarian Reserve: Prospective Study
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv
Started Jun 2018
Longer than P75 for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
June 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedJune 28, 2018
June 1, 2018
4 years
May 29, 2018
June 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Month 0 (inclusion visit), Month 6 (after 6 months), Month 12 (after one year), Month18 (after 18 months)
Study Arms (2)
case
EXPERIMENTALPLWH
control
OTHERHIV negative women, going to medically assisted procreation consultation for male infertility
Interventions
Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve
Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve
Eligibility Criteria
You may qualify if:
- For every participant :
- woman aged 18 to 37
- covered by social security
- able to give an informed consent
- Case group only :
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Clermont-Ferrand
Clermont-Ferrand, 63003, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Florence BRUGNON
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- No masking
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2018
First Posted
June 28, 2018
Study Start
June 1, 2018
Primary Completion
June 1, 2022
Study Completion
November 1, 2022
Last Updated
June 28, 2018
Record last verified: 2018-06