Preparing and timing of the endometrium in modified natural cycle frozen-thawed embryo transfer (mNC-FET) - A randomized controlled multicenter trial

Preparing and timing of the endometrium in modified natural cycle frozen-thawed embryo transfers (mNC-FET) - a randomized controlled multicenter trial - FET OPT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002207-34-DK

Enrollment

670

Registered

2018-06-15

Start date

2018-08-29

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility MedDRA version: 21.0 Level: PT Classification code 10021926 Term: Infertility System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: Lutinus Pharmaceutical Form: Capsule INN or Proposed INN: PROGESTERONE CAS Number: 57-83-0 Current Sponsor code: 25967 Other descriptive name: Lutinus Concentration unit: mg milligram(s) C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria ? Female age 18-41 years ? Regular menstrual cycle (23-35 days) ? Vitrified blastocysts derived from 1.-3. IVF/ICSI cycle resulting in an embryo transfer in a public hospital ? Undergoing single blastocyst transfer. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 670 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: (1) To assess if luteal phase support in modified natural cycle frozen-thawed embryo transfer (mNC-FET) is superior to no luteal phase support in terms of live birth rates per transfer and (2) To assess if warming+transfer 6 days after hCG is superior to warming+transfer 7 days after hCG in terms of live birth rates per transfer in mNC-FET.;Secondary Objective: 1)To investigate endocrine profiles in blood samples of women undergoing mNC-FET with or without luteal phase progesterone support. 2)To compare treatment outcomes including biochemical and clinical pregnancy rates, miscarriage rates and obstetric complications. 3)To compare neonatal outcomes (way of birth (vaginal birth or caesarean section), indication for caesarean section, use of forceps or cup during birth, sex of child, birth weight and length, gestational age, potential complications during pregnancy and birth, malformations and admission to neonatal intensive care unit). 4)To compare quality of life of women receiving and not receiving luteal phase progesterone support. ;Primary end point(s): 1) A 10% increase in live birth rate in the groups receiving luteal phase progesterone support compared to the groups not receiving luteal phase progesterone support. 2) A 10% increase in live birth in the groups undergoing frozen embryo transfer day six following ovulation trigger compared to day seven following ovulation trigger.;Timepoint(s) of evaluation of this end point: 6 years from start of inclusion, 1 year after last patient is recruited.	—

Measure

Time frame

Main Objective: (1) To assess if luteal phase support in modified natural cycle frozen-thawed embryo transfer (mNC-FET) is superior to no luteal phase support in terms of live birth rates per transfer and (2) To assess if warming+transfer 6 days after hCG is superior to warming+transfer 7 days after hCG in terms of live birth rates per transfer in mNC-FET.;Secondary Objective: 1)To investigate endocrine profiles in blood samples of women undergoing mNC-FET with or without luteal phase progesterone support. 2)To compare treatment outcomes including biochemical and clinical pregnancy rates, miscarriage rates and obstetric complications. 3)To compare neonatal outcomes (way of birth (vaginal birth or caesarean section), indication for caesarean section, use of forceps or cup during birth, sex of child, birth weight and length, gestational age, potential complications during pregnancy and birth, malformations and admission to neonatal intensive care unit). 4)To compare quality of life of women receiving and not receiving luteal phase progesterone support. ;Primary end point(s): 1) A 10% increase in live birth rate in the groups receiving luteal phase progesterone support compared to the groups not receiving luteal phase progesterone support. 2) A 10% increase in live birth in the groups undergoing frozen embryo transfer day six following ovulation trigger compared to day seven following ovulation trigger.;Timepoint(s) of evaluation of this end point: 6 years from start of inclusion, 1 year after last patient is recruited.

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Secondary

Measure	Time frame
Secondary end point(s): Additional endpoints include assessment of other relevant aspects of mNC-FET including chemical and clinical pregnancy rates, miscarriage rates and obstetric and neonatal outcomes in the study groups. Furthermore, endocrine blood samples will be collected in all study groups to determine if an endocrine profile compatible and not compatible with conception, can be identified. Lastly, quality of life questionnaires, from patients receiving and not receiving vaginal luteal phase support will be compared, having patient wellbeing as a focus point.;Timepoint(s) of evaluation of this end point: 6 years from start of inclusion, 1 year after last patient is recruited.	—

Measure

Time frame

Secondary end point(s): Additional endpoints include assessment of other relevant aspects of mNC-FET including chemical and clinical pregnancy rates, miscarriage rates and obstetric and neonatal outcomes in the study groups. Furthermore, endocrine blood samples will be collected in all study groups to determine if an endocrine profile compatible and not compatible with conception, can be identified. Lastly, quality of life questionnaires, from patients receiving and not receiving vaginal luteal phase support will be compared, having patient wellbeing as a focus point.;Timepoint(s) of evaluation of this end point: 6 years from start of inclusion, 1 year after last patient is recruited.

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Countries

Denmark

Contacts

Public ContactProfessor dr.med.

Anja Pinborg

anja.bisgaard.pinborg@regionh.dk004535456430

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026