Luteal Phase InsufficiencyCineP4NCT07028710
Early Luteal Phase Progesterone Kinetics After hCG-Induced Ovulation in Modified Natural Cycle
A study testing hCG in people with Luteal Phase Insufficiency, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This pilot study evaluates how progesterone levels change after hCG-triggered ovulation in modified natural cycles. Forty women preparing for frozen embryo transfer will have blood tests over 6 days to monitor hormone levels. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Luteal Phase Insufficiency
- What is being tested?
- hCG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2026to 15 Jun 2030
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- At least 1 follicle of 14 mm or more
- Endometrium of 6 mm or more
- Plasma luteinizing hormone (LH) less than 2 times basal level (measured at the beginning of the cycle between D1 and D4) and progesteronemia less than 1.5 ng/mL
- For whom ovulation induction with recombinant hCG (Ovitrelle) is then proposed (standard care).
Who cannot join
- Patient whose venous capital contraindicates repeated blood sampling over a short period of time over a short period.
- Patient treated with exogenous natural progesterone (vaginal or injectable) which may interfere or synthetic progesterone, which may interfere with endogenous progesterone secretion.
- Patient who has not given written consent to participate in the study.
- Patient not fluent in French.
- Patient under guardianship, curators or without social security coverage.
- Patient participating in another study with an ongoing exclusion period or other interventional research with no ongoing exclusion period involves the use of a drug or procedure capable of altering progesterone levels .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Noémie RANISAVLJEVIC, Senior Lecturer - Hospital Pra contact
France1 site, 1 recruiting
- Recruiting
Hôpital Arnaud de Villeneuve
Montpellier, 34000
Noémie RANISAVLJEVIC, 04 67 33 64 81 ext. +33, n-ranisavljevic@chu-montpellier.fr
About this study
Official title: Evolution of Luteal Progesteronemia in a Modified Natural Cycle (Ovulation Triggered by hCG): Pilot Study
This pilot study evaluates how progesterone levels change after hCG-triggered ovulation in modified natural cycles. Forty women preparing for frozen embryo transfer will have blood tests over 6 days to monitor hormone levels. The goal is to understand whether hCG affects the timing of the luteal phase and embryo implantation.
- Conditions
- Luteal Phase Insufficiency
- Being tested
- hCG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hCGDrug
Subcutaneous injection of 250 µg of recombinant hCG (Ovitrelle®)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: hCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Progesterone Level on Day 3 After hCG Trigger
Measured: 3 Days After hCG Injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start12 Jan 2026
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Luteal Phase InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noémie RANISAVLJEVIC, Investigator Coordinator, Principal investigator, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028710
- Sponsor's protocol ID
- RECHMPL24_0200
- Acronym
- CineP4
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mizrachi Y, Horowitz E, Ganer Herman H, Farhi J, Raziel A, Weissman A. Should women receive luteal support following natural cycle frozen embryo transfer? A systematic review and meta-analysis. Hum Reprod Update. 2021 Jun 22;27(4):643-650. doi: 10.1093/humupd/dmab011.
PubMed 33829269Lee VC, Li RH, Chai J, Yeung TW, Yeung WS, Ho PC, Ng EH. Effect of preovulatory progesterone elevation and duration of progesterone elevation on the pregnancy rate of frozen-thawed embryo transfer in natural cycles. Fertil Steril. 2014 May;101(5):1288-93. doi: 10.1016/j.fertnstert.2014.01.040. Epub 2014 Mar 3.
PubMed 24602752
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Luteal Progesteronemia in a Modified Natural Cycle (Ovulation Triggered by hCG): Pilot Study
- ClinicalTrials.gov ID
- NCT07028710
- Acronym / sponsor ID
- CineP4 / RECHMPL24_0200
- Conditions
- Luteal Phase Insufficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Jun 2030 (estimated)
- First posted
- 19 Jun 2025 (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.
This pilot study evaluates how progesterone levels change after hCG-triggered ovulation in modified natural cycles. Forty women preparing for frozen embryo transfer will have blood tests over 6 days to monitor hormone levels. The goal is to understand whether hCG affects the timing of the luteal phase and embryo implantation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: hCG |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- At least 1 follicle of 14 mm or more
- Endometrium of 6 mm or more
- Plasma luteinizing hormone (LH) less than 2 times basal level (measured at the beginning of the cycle between D1 and D4) and progesteronemia less than 1.5 ng/mL
- For whom ovulation induction with recombinant hCG (Ovitrelle) is then proposed (standard care).
Key exclusion criteria (6 listed)
- Patient whose venous capital contraindicates repeated blood sampling over a short period of time over a short period.
- Patient treated with exogenous natural progesterone (vaginal or injectable) which may interfere or synthetic progesterone, which may interfere with endogenous progesterone secretion.
- Patient who has not given written consent to participate in the study.
- Patient not fluent in French.
- Patient under guardianship, curators or without social security coverage.
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 |
|---|---|---|
| hCGSubcutaneous injection of 250 µg of recombinant hCG (Ovitrelle®) | Drug | 1 |
Primary outcome
Serum Progesterone Level on Day 3 After hCG Trigger
Time frame: 3 Days After hCG Injection
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 22 Jun 2026.
- Background: PubMed 33829269Mizrachi Y, Horowitz E, Ganer Herman H, Farhi J, Raziel A, Weissman A. Should women receive luteal support following natural cycle frozen embryo transfer? A systematic review and meta-analysis. Hum Reprod Update. 2021 Jun 22;27(4):643-650. doi: 10.1093/humupd/dmab011.
- Background: PubMed 24602752Lee VC, Li RH, Chai J, Yeung TW, Yeung WS, Ho PC, Ng EH. Effect of preovulatory progesterone elevation and duration of progesterone elevation on the pregnancy rate of frozen-thawed embryo transfer in natural cycles. Fertil Steril. 2014 May;101(5):1288-93. doi: 10.1016/j.fertnstert.2014.01.040. Epub 2014 Mar 3.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Luteal Phase Insufficiency
RecruitingPhase 1
First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency
Luteal Phase Insuffiency, Progesterone Delivery
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.
Noémie RANISAVLJEVIC, Senior Lecturer - Hospital Pra contact
Noémie RANISAVLJEVIC, Investigator Coordinator principal investigator
CHU de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hCG in people with Luteal Phase Insufficiency, run by University Hospital, Montpellier 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 4 inclusion and 6 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 22 Jun 2026. 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 Noémie RANISAVLJEVIC, Senior Lecturer - Hospital Pra (04 67 33 64 81, n-ranisavljevic@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Progesterone Level on Day 3 After hCG Trigger (time frame: 3 Days After hCG Injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07028710, which also lists 2 linked publications.
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 22 Jun 2026.