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HIV and Ovarian Reserve (VIHRO)

Primary Purpose

HIV, Infertility

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
AMH test
pelvic ultrasound
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HIV focused on measuring HIV, Ovarian reserve, Fertility preservation, Anti HIV agents

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Chu Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

case

control

Arm Description

PLWH

HIV negative women, going to medically assisted procreation consultation for male infertility

Outcomes

Primary Outcome Measures

change from inclusion visit AMH level at 18 months
blood test to evaluate ovarian reserve thanks to AMH

Secondary Outcome Measures

antral follicle count
pelvic ultrasound to evaluate ovarian reserve thanks to antral follicle count
estradiol, lutenizing hormone and follicle-stimulating hormone test
blood test

Full Information

First Posted
May 29, 2018
Last Updated
June 26, 2018
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03572270
Brief Title
HIV and Ovarian Reserve
Acronym
VIHRO
Official Title
Evaluation of the Potential Impact of HIV and Its Treatments on Ovarian Reserve: Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2018 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Infertility
Keywords
HIV, Ovarian reserve, Fertility preservation, Anti HIV agents

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
No masking
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
case
Arm Type
Experimental
Arm Description
PLWH
Arm Title
control
Arm Type
Other
Arm Description
HIV negative women, going to medically assisted procreation consultation for male infertility
Intervention Type
Diagnostic Test
Intervention Name(s)
AMH test
Intervention Description
Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve
Intervention Type
Diagnostic Test
Intervention Name(s)
pelvic ultrasound
Intervention Description
Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve
Primary Outcome Measure Information:
Title
change from inclusion visit AMH level at 18 months
Description
blood test to evaluate ovarian reserve thanks to AMH
Time Frame
M0 (inclusion visit) and M18 (after 18 months)
Secondary Outcome Measure Information:
Title
antral follicle count
Description
pelvic ultrasound to evaluate ovarian reserve thanks to antral follicle count
Time Frame
Month 0 (inclusion visit), Month 6 (after 6 months), Month12 (after one year), Month18 (after 18 months)
Title
estradiol, lutenizing hormone and follicle-stimulating hormone test
Description
blood test
Time Frame
Month 0 (inclusion visit), Month 6 (after 6 months), Month 12 (after one year), Month18 (after 18 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence BRUGNON
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Florence BRUGNON
First Name & Middle Initial & Last Name & Degree
Christine JACOMET
First Name & Middle Initial & Last Name & Degree
Anne-Sophie GREMEAU
First Name & Middle Initial & Last Name & Degree
Jean-Luc POULY
First Name & Middle Initial & Last Name & Degree
Vincent SAPIN

12. IPD Sharing Statement

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