Chemotherapy-Induced AmenorrheaMETAB-OVNCT05007834
Metabolism, Circadian Rhythms and Ovarian Function
An observational study of Chemotherapy-Induced Amenorrhea, run by University Hospital, Lille at 1 site in France.
Trial summary
Chemotherapy for cancer, due to its gonadotoxicity, can lead to impaired female fertility, resulting in the occurrence of transient or prolonged chemo-induced amenorrhea (CIA). According to recent data from the National Cancer Institute, 11.9% of women under the age of 40 diagnosed with cancer have been offered a… Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Chemotherapy-Induced Amenorrhea
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2022to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with a chemotherapy-induced (CIA) amenorrhea who asked for post-cancer fertility follow-up at the University Hospital of Lille, France.
Who may be able to join
- Women with a chemotherapy-induced (CIA) amenorrhea who asked for post-cancer fertility follow-up at the University Hospital of Lille, France.
- Women between 25 to 35 years age at inclusion
- Chemotherapy protocol: FEC 100 (3 cycles) + docetaxel (3 cycles
Who cannot join
- Women without CIA
- Women who refuse to participate in the study
- Women older than 35 years at inclusion
- Women who received another chemotherapy protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Metabolic Status and Circadian Rhythms on Post-chemotherapy Ovarian Recovery in Women Treated for Breast Cancer
Chemotherapy for cancer, due to its gonadotoxicity, can lead to impaired female fertility, resulting in the occurrence of transient or prolonged chemo-induced amenorrhea (CIA). According to recent data from the National Cancer Institute, 11.9% of women under the age of 40 diagnosed with cancer have been offered a fertility evaluation within five years of diagnosis. Predicting the risk and especially the duration of the CIA remains difficult. Known factors predicting a rapid return of menstruation are a young age at diagnosis, a low gonadotoxic treatment (absence of alkylating agents) and a high pre-chemotherapy blood level of AMH reflecting a large pool of growing follicles. A body mass index (BMI) ≥ 25 kg / m² could also be a positive predictor, but this remains debated.
The objective of this project is to assess the impact of metabolism and energy reserves, physical activity and the chronotype on the recovery of ovarian function in patients with breast cancer who have developed CIA
- Conditions
- Chemotherapy-Induced Amenorrhea
- Keywords
- Ovarian recovery, Metabolism, Muscular mass, Adipose tissue, Chronotype
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of IL-6 levels at the end of chemotherapy
Study the association between the IL-6 blood levels (in pg/ml) at the end of chemotherapy and the menstrual period return state ( before or after 6 months)
Measured: 1 year
Secondary outcomes (11)
Correlation between blood metabolic markers (Leptin, Insulin, Ghrelin) and menstrual period return state
Leptin concentration in ng/ml; insulin concentration in mUI/L; ghrelin concentrations in pg/ml
Measured: 1 year
Correlation between physical activity score at the end of chemotherapy and menstrual period return state
Physical activity score expressed in arbitrary units
Measured: 1 year
Correlation between chronotype score at the end of chemotherapy and menstrual period return state
chronotype score expressed in arbitrary units
Measured: 1 year
Correlation between the BMI at the end of chemotherapy and menstrual period return state
weight and height will be combined to report BMI in kg/m2
Measured: 1 year
Correlation between Blood metabolic markers (Leptin, Insulin, Ghrelin) assessed at 3 months and menstrual period return state
Leptin concentration in ng/ml, Insulin concentration in mUI/L, Ghrelin concentration in pg/ml
Measured: 9 months
Correlation between the Physical activity Score at 3 months and the menstrual period return state (between 3 to 12 months)
Physical activity score expressed in arbitrary units
Measured: 9 months
Correlation between the BMI assessed at 3 months and the menstrual period return state (between 3 to 12 months)
weight and height assessed at 3 months will be combined to report BMI in kg/m2
Measured: 9 months
Evolution of the blood concentration of insulin over the follow-up period (12 months)
insulin concentrations expressed in mUI/L
Measured: 1 year
Correlation between the Chronotype Score at 3 months and the menstrual period return state (between 3 to 12 months)
chronotype score expressed in arbitrary units
Measured: 9 months
Evolution of the blood concentration of Leptin over the follow-up period (12 months)
leptin concentrations expressed in ng/ml
Measured: 1 year
Evolution of the blood concentration of Ghrelin over the follow-up period (12 months)
ghrelin concentrations expressed in pg/ml
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start24 Feb 2022
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced AmenorrheaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal PIGNY, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007834
- Sponsor's protocol ID
- 2020_16
- Other IDs
- 2021-A00461-40
- Acronym
- METAB-OV
- Status last verified
- Dec 2025
- First submitted
- 20 May 2021
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Metabolic Status and Circadian Rhythms on Post-chemotherapy Ovarian Recovery in Women Treated for Breast Cancer
- ClinicalTrials.gov ID
- NCT05007834
- Acronym / sponsor ID
- METAB-OV / 2020_16
- Conditions
- Chemotherapy-Induced Amenorrhea
- Keywords
- Ovarian recovery, Metabolism, Muscular mass, Adipose tissue, Chronotype
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 16 Aug 2021 (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.
Chemotherapy for cancer, due to its gonadotoxicity, can lead to impaired female fertility, resulting in the occurrence of transient or prolonged chemo-induced amenorrhea (CIA). According to recent data from the National Cancer Institute, 11.9% of women under the age of 40 diagnosed with cancer have been offered a fertility evaluation within five years of diagnosis. Predicting the risk and especially the duration of the CIA remains difficult. Known factors predicting a rapid return of menstruation are a young age at diagnosis, a low gonadotoxic treatment (absence of alkylating agents) and a high pre-chemotherapy blood level of AMH reflecting a large pool of growing follicles. A body mass index (BMI) ≥ 25 kg / m² could also be a positive predictor, but this remains debated.
The objective of this project is to assess the impact of metabolism and energy reserves, physical activity and the chronotype on the recovery of ovarian function in patients with breast cancer who have developed CIA
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with a chemotherapy-induced (CIA) amenorrhea who asked for post-cancer fertility follow-up at the University Hospital of Lille, France.
Key inclusion criteria (3 listed)
- Women with a chemotherapy-induced (CIA) amenorrhea who asked for post-cancer fertility follow-up at the University Hospital of Lille, France.
- Women between 25 to 35 years age at inclusion
- Chemotherapy protocol: FEC 100 (3 cycles) + docetaxel (3 cycles
Key exclusion criteria (4 listed)
- Women without CIA
- Women who refuse to participate in the study
- Women older than 35 years at inclusion
- Women who received another chemotherapy protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concentration of IL-6 levels at the end of chemotherapy
Time frame: 1 year
Study the association between the IL-6 blood levels (in pg/ml) at the end of chemotherapy and the menstrual period return state ( before or after 6 months)
11 secondary outcomes
Correlation between blood metabolic markers (Leptin, Insulin, Ghrelin) and menstrual period return state
Time frame: 1 year
Correlation between physical activity score at the end of chemotherapy and menstrual period return state
Time frame: 1 year
Correlation between chronotype score at the end of chemotherapy and menstrual period return state
Time frame: 1 year
Correlation between the BMI at the end of chemotherapy and menstrual period return state
Time frame: 1 year
Correlation between Blood metabolic markers (Leptin, Insulin, Ghrelin) assessed at 3 months and menstrual period return state
Time frame: 9 months
Correlation between the Physical activity Score at 3 months and the menstrual period return state (between 3 to 12 months)
Time frame: 9 months
Correlation between the BMI assessed at 3 months and the menstrual period return state (between 3 to 12 months)
Time frame: 9 months
Evolution of the blood concentration of insulin over the follow-up period (12 months)
Time frame: 1 year
Correlation between the Chronotype Score at 3 months and the menstrual period return state (between 3 to 12 months)
Time frame: 9 months
Evolution of the blood concentration of Leptin over the follow-up period (12 months)
Time frame: 1 year
Evolution of the blood concentration of Ghrelin over the follow-up period (12 months)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
Related trials for Chemotherapy-Induced Amenorrhea
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Breast Cancer, Perimenopause
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.
Pascal PIGNY, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-Induced Amenorrhea, run by University Hospital, Lille 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 26 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pascal PIGNY, MD,PhD (0320445962 ext. +33, pascal.pigny@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of IL-6 levels at the end of chemotherapy (time frame: 1 year). 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 26 Dec 2025.