HIVVIHRONCT03572270
HIV and Ovarian Reserve
A study testing AMH test and pelvic ultrasound in people with HIV and Infertility, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Infertility
- What is being tested?
- AMH test and pelvic ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2018to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr
Florence BRUGNON
About this study
Official title: Evaluation of the Potential Impact of HIV and Its Treatments on Ovarian Reserve: Prospective Study
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.
Read the 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.
- Conditions
- HIV, Infertility
- Being tested
- AMH test, pelvic ultrasound
- Keywords
- HIV, Ovarian reserve, Fertility preservation, Anti HIV agents
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMH testDiagnostic test
Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve
pelvic ultrasoundDiagnostic test
Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve
| Study group | Role | What they receive |
|---|---|---|
| case | Experimental | PLWH Receives: Diagnostic Test: AMH test; Diagnostic Test: pelvic ultrasound |
| control | Other | HIV negative women, going to medically assisted procreation consultation for male infertility Receives: Diagnostic Test: AMH test; Diagnostic Test: pelvic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from inclusion visit AMH level at 18 months
blood test to evaluate ovarian reserve thanks to AMH
Measured: M0 (inclusion visit) and M18 (after 18 months)
Secondary outcomes (2)
antral follicle count
pelvic ultrasound to evaluate ovarian reserve thanks to antral follicle count
Measured: 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
Measured: Month 0 (inclusion visit), Month 6 (after 6 months), Month 12 (after one year), Month18 (after 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study startJun 2018 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence BRUGNON, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572270
- Sponsor's protocol ID
- CHU-391
- Other IDs
- 2017-A03469-44
- Acronym
- VIHRO
- Status last verified
- Jun 2018
- First submitted
- 29 May 2018
- Last updated
- 28 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Potential Impact of HIV and Its Treatments on Ovarian Reserve: Prospective Study
- ClinicalTrials.gov ID
- NCT03572270
- Acronym / sponsor ID
- VIHRO / CHU-391
- Conditions
- HIV, Infertility
- Keywords
- HIV, Ovarian reserve, Fertility preservation, Anti HIV agents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 28 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | Experimental | Diagnostic Test: AMH test, Diagnostic Test: pelvic ultrasoundPLWH |
| control | Other | Diagnostic Test: AMH test, Diagnostic Test: pelvic ultrasoundHIV negative women, going to medically assisted procreation consultation for male infertility |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- For every participant :
- woman aged 18 to 37
- covered by social security
- able to give an informed consent
- diagnosis of HIV infection during the 3 months before inclusion
Key exclusion criteria (8 listed)
- For every participant :
- current pregnancy
- condition or associated treatment that may have an impact on fertility
- premature ovarian failure
- polycystic ovary syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMH testBlood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve | Diagnostic test | case, control |
| pelvic ultrasoundBlood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve | Diagnostic test | case, control |
Primary outcome
change from inclusion visit AMH level at 18 months
Time frame: M0 (inclusion visit) and M18 (after 18 months)
blood test to evaluate ovarian reserve thanks to AMH
2 secondary outcomes
antral follicle count
Time frame: 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
Time frame: Month 0 (inclusion visit), Month 6 (after 6 months), Month 12 (after one year), Month18 (after 18 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence BRUGNON principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMH test and pelvic ultrasound in people with HIV and Infertility, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from inclusion visit AMH level at 18 months (time frame: M0 (inclusion visit) and M18 (after 18 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.