InfertilityPhase 4NCT03795220
Preparing and Timing of the Endometrium in Modified Natural Cycle Frozen-thawed Embryo Transfers
A Phase 4 study testing Lutinus + transfer day 6, Lutinus + transfer day 7 and No Lutinus + transfer day 6 in people with Infertility, run by Anja Bisgaard Pinborg at 1 site in Denmark.
Trial summary
The increasing use of FET emphasizes the importance of preparing and timing the endometrium in FET cycles, however there is no consensus on luteal phase progesterone supplementation in mNC-FET and the optimal day of blastocyst warming and transfer. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Lutinus + transfer day 6, Lutinus + transfer day 7 and No Lutinus + transfer day 6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 679 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Jan 2019to 31 Dec 2024
- Phase
- Phase 4
- 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 41 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female age 18-41 years, regular menstrual cycle (23-35 days), vitrified blastocysts derived from 1.-3. IVF/ICSI cycle in a public hospital and undergoing single blastocyst transfer.
Who cannot join
- Previous participation in the study, uterine malformations, intrauterine polyps or submucosal myomas, breast feeding, oocyte donation, preimplantation genetic testing, blastocyst conceived with sperm from testicular sperm aspiration, HIV (woman), hepatitis B and C (woman), known luteal phase insufficiency or if patients are not fulfilling the inclusion criteria. Further exclusion criteria are the following contraindications to progesterone; allergy to the study medication, undiagnosed vaginal bleeding, current missed abortion or ectopic pregnancy, hepatic insufficiency or severe hepatic disease, genital or breast cancer, arterial or venous thromboembolism, thrombophlebitis or porphyria. For patients participating in the sub-study, thyroid disease is an exclusion criterion.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Fertility Clinic, Rigshospitalet, Copenhagen University Hospital
Copenhagen, 2100
About this study
Official title: Preparing and Timing of the Endometrium in Modified Natural Cycle Frozen-thawed Embryo Transfers (mNC-FET) - a Randomized Controlled Multicenter Trial
The increasing use of FET emphasizes the importance of preparing and timing the endometrium in FET cycles, however there is no consensus on luteal phase progesterone supplementation in mNC-FET and the optimal day of blastocyst warming and transfer. The aim of this multicenter RCT is to assess the effect of progesterone supplementation in hCG-triggered mNC-FET and the effect of embryo thawing and transfer at hCG+6 or hCG+7 days, respectively. In total 604 patients will be included with n=151 in each of the four study arms. The primary outcome is live birth rate per transfer (LBR) and the goal is to show a 10% increase in LBR after progesterone supplementation and to assess whether blastocyst warming+transfer 6 days after hCG trigger is superior to 7 days after hCG trigger in mNC-FET.
Read the detailed description
Single embryo transfer and freezing of surplus embryos has lowered twin birth rates after in vitro fertilization (IVF) to a level of less than 5% in Denmark. However, several treatments with repeated frozen embryo transfers (FET) before a viable pregnancy is confirmed are burdensome to the patients. New freezing techniques has optimized the quality of the embryo transferred in FET cycles, but optimization of the endometrium in the luteal phase is still lacking behind. In a mNC-FET, which is the routine in many clinics, ovulation is induced with an hCG injection when the leading follicle is ≥17 mm. The hCG trigger is important for controlling the time of ovulation, but triggering an unhealthy follicle at an inappropriate time may cause luteal phase insufficiency and thus suboptimal function of the endometrium. Danish public fertility clinics are not routinely using progesterone supplementation in mNC-FET, but there may be a rationale to do so, and some implantations may be rescued. In this study we will compare live birth rates in mNC-FET with and without progesterone supplementation in the luteal phase, and further we will explore the optimal timing of blastocyst warming and transfer by comparing embryo transfer at hCG trigger +6 days versus +7 days. This is a superiority study with the aim to detect an increase in live birth rates of 10%. Hence, this adequately powered RCT may make a major contribution to knowledge on mNC-FET to the benefits of patients. We will include 604 patients divided 1:1 (302:302) in each arm +/- progesterone and these will further be divided 1:1 in blastocyst warming and transfer +6 and +7 days after hCG injection. The primary endpoint is live birth rate per transfer.
- Conditions
- Infertility
- Being tested
- Lutinus + transfer day 6, Lutinus + transfer day 7, No Lutinus + transfer day 6, No Lutinus + transfer day 7
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutinus + transfer day 6Drug
Also called Lutinus
Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger.
Lutinus + transfer day 7Drug
Also called Lutinus
Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger.
No Lutinus + transfer day 6Drug
Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger.
No Lutinus + transfer day 7Drug
Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal progesterone + transfer 6. day | Active comparator | Lutinus + blastocyst warming and transfer 6 days after hCG trigger Receives: Drug: Lutinus + transfer day 6 |
| Vaginal progesterone + transfer 7. day | Active comparator | Lutinus + blastocyst warming and transfer 7 days after hCG trigger Receives: Drug: Lutinus + transfer day 7 |
| No progesterone + transfer 6. day | Active comparator | No Lutinus + blastocyst warming and transfer 6 days after hCG trigger Receives: Drug: No Lutinus + transfer day 6 |
| No progesterone + transfer 7. day | Active comparator | No Lutinus + blastocyst warming and transfer 7 days after hCG trigger Receives: Drug: No Lutinus + transfer day 7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rates per transfer
Comparison of live birth rates between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger.
Measured: Registered at the one-year follow-up after a positive pregnancy test.
Secondary outcomes (17)
Chemical pregnancy rates per transfer
Comparison of chemical pregnancy rates between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger.
Measured: Measured 16 days after ovulation trigger (hCG+16).
Clinical pregnancy rates per transfer
Comparison of clinical pregnancy rates (ultrasound) between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or seven after hCG trigger.
Measured: Ultrasound performed at 7-8 weeks of gestation.
Abortion rates per transfer
Comparison of abortion rates between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger.
Measured: Registered at the one-year follow-up after a positive pregnancy test.
ASAT (U/L)
ALAT measured by blood sample to ensure normal liver parameters before administration of progesterone.
Measured: Measured at baseline.
ALAT (U/L)
ALAT measured by blood sample to ensure normal liver parameters before administration of progesterone.
Measured: Measured at baseline.
AMH (pol/L)
Comparison of AMH measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger.
Measured: Measured at baseline.
Estradiole (mmol/L)
Comparison of estradiole measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger.
Measured: Measured at baseline, at ovulation trigger day (hCG+0), at transfer day (hCG+6/7) and at hCG+11.
FSH (IU/L)
Comparison of FSH measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger.
Measured: Measured at baseline, at ovulation trigger day (hCG+0), at transfer day (hCG+6/7) and at hCG+11.
LH (IU/L)
Comparison of LH measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger.
Measured: Measured at baseline, at ovulation trigger day (hCG+0), at transfer day (hCG+6/7) and at hCG+11.
Progesterone (nmol/L)
Comparison of progesterone measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger.
Measured: Measured at baseline, at ovulation trigger day (hCG+0), at transfer day (hCG+6/7) and at hCG+11.
OH-progesterone (nmol/L)
Comparison OH-progesterone measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger.
Measured: Measured at ovulation trigger day (hCG+0), at transfer day (hCG+6/7) and at hCG+11.
beta-hCG
Comparison of beta-hCG measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger.
Measured: Measured at transfer day (hCG+6/7), hCG+11 and hCG+16.
TSH (*10^3 IU/L)
Comparison of TSH measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger.
Measured: Measured at baseline, at ovulation trigger day (hCG+0), at transfer day (hCG+6/7), at hCG+11, at hCG+14 and at hCG+19.
Thyroglobulin antibodies (arb.units/L)
Comparison of thyroglobulin antibodies measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger.
Measured: Measured at baseline.
Thyroid peroxidase anitbodies (arb.units/L)
Comparison of thyroid peroxidase antibodies measured by blood samples between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger.
Measured: Measured at baseline.
Obstetric complication rates
Comparison of obstetric complication rates between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger.
Measured: Registered at the one-year follow-up after a positive pregnancy test.
Neonatal complication rates
Comparison of neonatal complication rates for children of patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger.
Measured: Registered at the one-year follow-up after a positive pregnancy test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start6 Jan 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled multicenter trial with inclusion of 604 mNC-FET cycles. We will include 604 patients divided 1:1 (302:302) in each arm +/- progesterone supplementation and these will further be divided 1:1 in blastocyst warming and transfer +6 and +7 days after hCG injection. Patients randomised to progesterone supplementation will start administering medicine four days after the ovulation trigger up til the day of the pregnancy test. If the pregnancy test is positive, medication will continue for 30 days more.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 679 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anja Bisgaard Pinborg
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre, Regionshospitalet Horsens, Copenhagen University Hospital at Herlev, Aalborg University Hospital, Hillerod Hospital, Denmark, Zealand University Hospital, Regionshospitalet Viborg, Skive
- Responsible party
- Sponsor-investigator, Anja Bisgaard Pinborg, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Anja B. Pinborg, Prof., DMSC, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795220
- Sponsor's protocol ID
- 63569
- Other IDs
- 2018-002207-34, 2018
- Status last verified
- Feb 2024
- First submitted
- 4 Dec 2018
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On request the study protocol and deidentified individual study data collected during the trial, including stored biobank samples, can be shared with research groups with relevant aims and a methodologically sound proposal. Approvals by necessary ethic committees and the Danish Data Protection Agency will be needed before sharing of data. All costs for data sharing will be covered by the party requesting the data. Data cannot be shared with groups working on research projects with the same aims, secondary aims or purposes. Further no data can be shared until 3 months after publication of first papers on the primary and secondary outcomes in this study. Biobank samples cannot be shared with research groups outside Denmark. Proposals of data sharing should be directed to anja.bisgaard.pinborg@regionh.dk. To gain access, data requestors will need to sign a data sharing agreement.
Publications
Saupstad M, Colombo C, Bergenheim SJ, Pistoljevic-Kristiansen N, Dam TV, Bogstad JW, Praetorius L, Freiesleben NC, Klajnbard A, Oxlund-Mariegaard B, Humaidan P, Lokkegaard ECL, Husth M, Knudsen UB, Gabrielsen A, Forman JL, Petersen MR, Lossl K, Pinborg A. Optimizing the protocol for modified natural cycle frozen embryo transfer (mNC-FET): a multicentre, single-blinded randomized controlled trial. Hum Reprod Open. 2026 Jan 13;2026(1):hoag003. doi: 10.1093/hropen/hoag003. eCollection 2026.
PubMed 41640422Colombo C, Pistoljevic-Kristiansen N, Saupstad M, Bergenheim SJ, Spangmose AL, Klajnbard A, la Cour Freiesleben N, Lokkegaard EC, Englund AL, Husth M, Breth Knudsen U, Alsbjerg B, Praetorius L, Lossl K, Schmidt L, Pinborg A. Does luteal phase progesterone supplementation affect physical and psychosocial well-being among women undergoing modified natural cycle-FET? A sub-study of a randomized controlled trial. Hum Reprod. 2023 Oct 3;38(10):1970-1980. doi: 10.1093/humrep/dead171.
PubMed 37634089Saupstad M, Freiesleben NC, Skouby SO, Andersen LF, Knudsen UB, Petersen KB, Husth M, Egeberg A, Petersen MR, Ziebe S, Andersen AN, Lossl K, Pinborg A. Preparation of the endometrium and timing of blastocyst transfer in modified natural cycle frozen-thawed embryo transfers (mNC-FET): a study protocol for a randomised controlled multicentre trial. BMJ Open. 2019 Dec 15;9(12):e031811. doi: 10.1136/bmjopen-2019-031811.
PubMed 31843833
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing and Timing of the Endometrium in Modified Natural Cycle Frozen-thawed Embryo Transfers (mNC-FET) - a Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT03795220
- Acronym / sponsor ID
- 63569
- Conditions
- Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 679 participants (actual)
- Lead sponsor
- Anja Bisgaard PinborgUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre, Regionshospitalet Horsens, Copenhagen University Hospital at Herlev, Aalborg University Hospital, Hillerod Hospital, Denmark, Zealand University Hospital, Regionshospitalet Viborg, Skive
- Study start
- 6 Jan 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 7 Jan 2019 (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 increasing use of FET emphasizes the importance of preparing and timing the endometrium in FET cycles, however there is no consensus on luteal phase progesterone supplementation in mNC-FET and the optimal day of blastocyst warming and transfer. The aim of this multicenter RCT is to assess the effect of progesterone supplementation in hCG-triggered mNC-FET and the effect of embryo thawing and transfer at hCG+6 or hCG+7 days, respectively. In total 604 patients will be included with n=151 in each of the four study arms. The primary outcome is live birth rate per transfer (LBR) and the goal is to show a 10% increase in LBR after progesterone supplementation and to assess whether blastocyst warming+transfer 6 days after hCG trigger is superior to 7 days after hCG trigger in mNC-FET.
Detailed description
Single embryo transfer and freezing of surplus embryos has lowered twin birth rates after in vitro fertilization (IVF) to a level of less than 5% in Denmark. However, several treatments with repeated frozen embryo transfers (FET) before a viable pregnancy is confirmed are burdensome to the patients. New freezing techniques has optimized the quality of the embryo transferred in FET cycles, but optimization of the endometrium in the luteal phase is still lacking behind. In a mNC-FET, which is the routine in many clinics, ovulation is induced with an hCG injection when the leading follicle is ≥17 mm. The hCG trigger is important for controlling the time of ovulation, but triggering an unhealthy follicle at an inappropriate time may cause luteal phase insufficiency and thus suboptimal function of the endometrium. Danish public fertility clinics are not routinely using progesterone supplementation in mNC-FET, but there may be a rationale to do so, and some implantations may be rescued. In this study we will compare live birth rates in mNC-FET with and without progesterone supplementation in the luteal phase, and further we will explore the optimal timing of blastocyst warming and transfer by comparing embryo transfer at hCG trigger +6 days versus +7 days. This is a superiority study with the aim to detect an increase in live birth rates of 10%. Hence, this adequately powered RCT may make a major contribution to knowledge on mNC-FET to the benefits of patients. We will include 604 patients divided 1:1 (302:302) in each arm +/- progesterone and these will further be divided 1:1 in blastocyst warming and transfer +6 and +7 days after hCG injection. The primary endpoint is live birth rate per transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- Randomized, controlled multicenter trial with inclusion of 604 mNC-FET cycles. We will include 604 patients divided 1:1 (302:302) in each arm +/- progesterone supplementation and these will further be divided 1:1 in blastocyst warming and transfer +6 and +7 days after hCG injection. Patients randomised to progesterone supplementation will start administering medicine four days after the ovulation trigger up til the day of the pregnancy test. If the pregnancy test is positive, medication will continue for 30 days more.
| Arm | Type | Receives |
|---|---|---|
| Vaginal progesterone + transfer 6. day | Active comparator | Drug: Lutinus + transfer day 6Lutinus + blastocyst warming and transfer 6 days after hCG trigger |
| Vaginal progesterone + transfer 7. day | Active comparator | Drug: Lutinus + transfer day 7Lutinus + blastocyst warming and transfer 7 days after hCG trigger |
| No progesterone + transfer 6. day | Active comparator | Drug: No Lutinus + transfer day 6No Lutinus + blastocyst warming and transfer 6 days after hCG trigger |
| No progesterone + transfer 7. day | Active comparator | Drug: No Lutinus + transfer day 7No Lutinus + blastocyst warming and transfer 7 days after hCG trigger |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female age 18-41 years, regular menstrual cycle (23-35 days), vitrified blastocysts derived from 1.-3. IVF/ICSI cycle in a public hospital and undergoing single blastocyst transfer.
Key exclusion criteria (1 listed)
- Previous participation in the study, uterine malformations, intrauterine polyps or submucosal myomas, breast feeding, oocyte donation, preimplantation genetic testing, blastocyst conceived with sperm from testicular sperm aspiration, HIV (woman), hepatitis B and C (woman), known luteal phase insufficiency or if patients are not fulfilling the inclusion criteria. Further exclusion criteria are the following contraindications to progesterone; allergy to the study medication, undiagnosed vaginal bleeding, current missed abortion or ectopic pregnancy, hepatic insufficiency or severe hepatic disease, genital or breast cancer, arterial or venous thromboembolism, thrombophlebitis or porphyria. For patients participating in the sub-study, thyroid disease is an exclusion criterion.
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 |
|---|---|---|
| Lutinus + transfer day 6Also: LutinusFour parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger. | Drug | Vaginal progesterone + transfer 6. day |
| Lutinus + transfer day 7Also: LutinusFour parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger. | Drug | Vaginal progesterone + transfer 7. day |
| No Lutinus + transfer day 6Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger. | Drug | No progesterone + transfer 6. day |
| No Lutinus + transfer day 7Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger. | Drug | No progesterone + transfer 7. day |
Primary outcome
Live birth rates per transfer
Time frame: Registered at the one-year follow-up after a positive pregnancy test.
Comparison of live birth rates between patients receiving and not receiving Lutinus, with blastocyst warming and transfer day 6 or 7 after hCG trigger.
17 secondary outcomes
Chemical pregnancy rates per transfer
Time frame: Measured 16 days after ovulation trigger (hCG+16).
Clinical pregnancy rates per transfer
Time frame: Ultrasound performed at 7-8 weeks of gestation.
Abortion rates per transfer
Time frame: Registered at the one-year follow-up after a positive pregnancy test.
ASAT (U/L)
Time frame: Measured at baseline.
ALAT (U/L)
Time frame: Measured at baseline.
AMH (pol/L)
Time frame: Measured at baseline.
Estradiole (mmol/L)
Time frame: Measured at baseline, at ovulation trigger day (hCG+0), at transfer day (hCG+6/7) and at hCG+11.
FSH (IU/L)
Time frame: Measured at baseline, at ovulation trigger day (hCG+0), at transfer day (hCG+6/7) and at hCG+11.
LH (IU/L)
Time frame: Measured at baseline, at ovulation trigger day (hCG+0), at transfer day (hCG+6/7) and at hCG+11.
Progesterone (nmol/L)
Time frame: Measured at baseline, at ovulation trigger day (hCG+0), at transfer day (hCG+6/7) and at hCG+11.
OH-progesterone (nmol/L)
Time frame: Measured at ovulation trigger day (hCG+0), at transfer day (hCG+6/7) and at hCG+11.
beta-hCG
Time frame: Measured at transfer day (hCG+6/7), hCG+11 and hCG+16.
TSH (*10^3 IU/L)
Time frame: Measured at baseline, at ovulation trigger day (hCG+0), at transfer day (hCG+6/7), at hCG+11, at hCG+14 and at hCG+19.
Thyroglobulin antibodies (arb.units/L)
Time frame: Measured at baseline.
Thyroid peroxidase anitbodies (arb.units/L)
Time frame: Measured at baseline.
Obstetric complication rates
Time frame: Registered at the one-year follow-up after a positive pregnancy test.
Neonatal complication rates
Time frame: Registered at the one-year follow-up after a positive pregnancy test.
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 15 May 2025.
- Derived from this study: PubMed 41640422Saupstad M, Colombo C, Bergenheim SJ, Pistoljevic-Kristiansen N, Dam TV, Bogstad JW, Praetorius L, Freiesleben NC, Klajnbard A, Oxlund-Mariegaard B, Humaidan P, Lokkegaard ECL, Husth M, Knudsen UB, Gabrielsen A, Forman JL, Petersen MR, Lossl K, Pinborg A. Optimizing the protocol for modified natural cycle frozen embryo transfer (mNC-FET): a multicentre, single-blinded randomized controlled trial. Hum Reprod Open. 2026 Jan 13;2026(1):hoag003. doi: 10.1093/hropen/hoag003. eCollection 2026.
- Derived from this study: PubMed 37634089Colombo C, Pistoljevic-Kristiansen N, Saupstad M, Bergenheim SJ, Spangmose AL, Klajnbard A, la Cour Freiesleben N, Lokkegaard EC, Englund AL, Husth M, Breth Knudsen U, Alsbjerg B, Praetorius L, Lossl K, Schmidt L, Pinborg A. Does luteal phase progesterone supplementation affect physical and psychosocial well-being among women undergoing modified natural cycle-FET? A sub-study of a randomized controlled trial. Hum Reprod. 2023 Oct 3;38(10):1970-1980. doi: 10.1093/humrep/dead171.
- Derived from this study: PubMed 31843833Saupstad M, Freiesleben NC, Skouby SO, Andersen LF, Knudsen UB, Petersen KB, Husth M, Egeberg A, Petersen MR, Ziebe S, Andersen AN, Lossl K, Pinborg A. Preparation of the endometrium and timing of blastocyst transfer in modified natural cycle frozen-thawed embryo transfers (mNC-FET): a study protocol for a randomised controlled multicentre trial. BMJ Open. 2019 Dec 15;9(12):e031811. doi: 10.1136/bmjopen-2019-031811.
- Individual participant dataSharing planned: Yes. On request the study protocol and deidentified individual study data collected during the trial, including stored biobank samples, can be shared with research groups with relevant aims and a methodologically sound proposal. Approvals by necessary ethic committees and the Danish Data Protection Agency will be needed before sharing of data. All costs for data sharing will be covered by the party requesting the data. Data cannot be shared with groups working on research projects with the same aims, secondary aims or purposes. Further no data can be shared until 3 months after publication of first papers on the primary and secondary outcomes in this study. Biobank samples cannot be shared with research groups outside Denmark. Proposals of data sharing should be directed to anja.bisgaard.pinborg@regionh.dk. To gain access, data requestors will need to sign a data sharing agreement.
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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.
Anja B. Pinborg, Prof., DMSC principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lutinus + transfer day 6, Lutinus + transfer day 7 and No Lutinus + transfer day 6 in people with Infertility, run by Anja Bisgaard Pinborg at 1 site in Denmark.
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 1 inclusion and 1 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 15 May 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Live birth rates per transfer (time frame: Registered at the one-year follow-up after a positive pregnancy test.). 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 NCT03795220, which also lists 3 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 15 May 2025.