in Vitro FertilizationTECNATNCT03428165
Transfer of Frozen Embryos in Natural Cycle: Evaluation of Impact of Spontaneous Versus HCG-triggered Ovulation on Pregnancy Rate
A study testing HCG in people with in Vitro Fertilization, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
The purpose of the study is to evaluated whether there is a difference in pregnancy rate when transferring frozen embryos between patietns having spontaneously ovulated versus those triggered to voulate with HCG. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- in Vitro Fertilization
- What is being tested?
- HCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Mar 2018to 1 Feb 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient is aged between 18 and 40
- Patient has regular cycles and classified as 'easy' for transfer of a frozen embryo at blastocyste stage (vitrification day 5)
Who cannot join
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient using donated oocytes
- Necessity of pre-implantation diagnosis
- Patients with stage 3 or 4 endometriosis or adenomyosis
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Arnaud de Villeneuve
Montpellier, 34295
CHU Nimes
Nîmes, 30029
About this study
Official title: Transfer of Frozen Embryos in NATural Cycle: Evaluation of Impact of Spontaneous Versus HCG-triggered Ovulation on Pregnancy Rate - Bicentric Prospective Open Randomized Controlled Trial
The purpose of the study is to evaluated whether there is a difference in pregnancy rate when transferring frozen embryos between patietns having spontaneously ovulated versus those triggered to voulate with HCG.
- Conditions
- in Vitro Fertilization
- Being tested
- HCG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCGOther
250 μg/0.5ml choriogonadotropine alpha, Ovitrelle, Merck Serono
| Study group | Role | What they receive |
|---|---|---|
| human chorionic gonadotropin (HCG) | Other | Ovulation triggered using HCG: choriogonadotropin alpha (Ovitrelle, Merck Serono), 250 μg/0.5ml Receives: Other: HCG |
| spontaneous | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate after transfer of frozen embryos at day 14 between groups
Yes/no; Blood ßHCG > 100UI/L
Measured: Day 14
Secondary outcomes (7)
Pregnancy rate at week 12
Yes/no; ultrasound
Measured: Week 12
Miscarriage rate within first 12 weeks
Yes/no; ultrasound
Measured: Week 12
Live birth
Yes/no
Measured: At delivery, maximum week 42
Pregnancy term
Weeks
Measured: At delivery, maximum week 42
Birth weight
Kg
Measured: At delivery, maximum week 42
Cancellation of transfer due to premature ovulation (progesterone >3ng/ml and/or Luteinizing hormone > 3-fold base level)
Yes/no
Measured: Day 0
Number of visits for endometrial preparation until attaining LH peak
Number of visits
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start7 Mar 2018
- Primary completion29 Jun 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for in Vitro FertilizationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie Huberlant, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428165
- Sponsor's protocol ID
- NIMAO/2017-02/SH-01
- Other IDs
- 2017-A02759-44
- Acronym
- TECNAT
- Status last verified
- Jun 2022
- First submitted
- 5 Feb 2018
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ranisavljevic N, Bonneau M, Rougier N, Hamamah S, Anahory T, Serand C, Huberlant S. Ovulation trigger versus spontaneous luteinizing hormone surge on live birth rate after frozen embryo transfer in a natural cycle: a randomized controlled trial. Fertil Steril. 2025 Apr;123(4):718-720. doi: 10.1016/j.fertnstert.2024.10.021. Epub 2024 Oct 19. No abstract available.
PubMed 39433204
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer of Frozen Embryos in NATural Cycle: Evaluation of Impact of Spontaneous Versus HCG-triggered Ovulation on Pregnancy Rate - Bicentric Prospective Open Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03428165
- Acronym / sponsor ID
- TECNAT / NIMAO/2017-02/SH-01
- Conditions
- in Vitro Fertilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 9 Feb 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.
The purpose of the study is to evaluated whether there is a difference in pregnancy rate when transferring frozen embryos between patietns having spontaneously ovulated versus those triggered to voulate with HCG.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| human chorionic gonadotropin (HCG) | Other | Other: HCGOvulation triggered using HCG: choriogonadotropin alpha (Ovitrelle, Merck Serono), 250 μg/0.5ml |
| spontaneous | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient is aged between 18 and 40
- Patient has regular cycles and classified as 'easy' for transfer of a frozen embryo at blastocyste stage (vitrification day 5)
Key exclusion criteria (7 listed)
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient using donated oocytes
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 |
|---|---|---|
| HCG250 μg/0.5ml choriogonadotropine alpha, Ovitrelle, Merck Serono | Other | human chorionic gonadotropin (HCG) |
Primary outcome
Pregnancy rate after transfer of frozen embryos at day 14 between groups
Time frame: Day 14
Yes/no; Blood ßHCG > 100UI/L
7 secondary outcomes
Pregnancy rate at week 12
Time frame: Week 12
Miscarriage rate within first 12 weeks
Time frame: Week 12
Live birth
Time frame: At delivery, maximum week 42
Pregnancy term
Time frame: At delivery, maximum week 42
Birth weight
Time frame: At delivery, maximum week 42
Cancellation of transfer due to premature ovulation (progesterone >3ng/ml and/or Luteinizing hormone > 3-fold base level)
Time frame: Day 0
Number of visits for endometrial preparation until attaining LH peak
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 39433204Ranisavljevic N, Bonneau M, Rougier N, Hamamah S, Anahory T, Serand C, Huberlant S. Ovulation trigger versus spontaneous luteinizing hormone surge on live birth rate after frozen embryo transfer in a natural cycle: a randomized controlled trial. Fertil Steril. 2025 Apr;123(4):718-720. doi: 10.1016/j.fertnstert.2024.10.021. Epub 2024 Oct 19. No abstract available.
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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.
Stéphanie Huberlant principal investigator
CHU Nimes
2 sites 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 in Vitro Fertilization, run by Centre Hospitalier Universitaire de Nīmes at 2 sites 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 7 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: finished, as of the sponsor's last update on 4 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 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate after transfer of frozen embryos at day 14 between groups (time frame: Day 14). 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 NCT03428165, which also lists 1 linked publication.
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 4 Dec 2025.