Status:
RECRUITING
Is There a Need for Luteal Support in Modified Natural Cycle Frozen Embryo Transfer Cycles
Lead Sponsor:
Dunamenti REK Istenhegyi IVF Center
Collaborating Sponsors:
Medical University of Pecs
Dunamenti REK Gyor Clinic
Conditions:
Luteal Support
Frozen Embryo Transfer (FET)
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
Without progesterone there is no pregnancy. Following ovulation, the endocrine function of the follicle changes and progesterone replacing estradiol becomes its main secretory product. In the follicul...
Detailed Description
Aim: The aim of this RCT is to assess whether the use of luteal support improves the outcome of modified natural cycle frozen embryo transfer (FET) treatments. Background: Without progesterone there ...
Eligibility Criteria
Inclusion
- Age 18-40 years at the time of vitrification
- At least one good quality blastocyst frozen
- Planned 1 blastocyst transfer
- \<3 failed previous ETs
- Cycle length between 21-35 days
- Body mass index (BMI): 18-35 kg/m2
- Intact uterine cavity based on hysteroscopy, hysteron-salpingogram, salina sonohysterogram
- Consent to participate
Exclusion
- Age \<18 of over 40 at the time of vitrification
- BMI: \<18 kg/m2 or \>35 kg/m2
- Planned transfer of more than 1 embryo
- Irregular cycles (\<21 or \>35 days)
- Use of a protocol other than the modified natural cycle frozen embryo transfer
- Lack of good morphology blastocysts
- No evidence for spontaneous follicle development (no dominant (\>17 mm) follicle by day 20 of cycle)
- Patient with a history of recurrent miscarriages
- Presence of a hydrosalpinx
- Irregular uterine cavity
- Positive test for HIV, hepatitis B or C
- Lack of consent
Key Trial Info
Start Date :
April 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06875752
Start Date
April 12 2025
End Date
December 1 2026
Last Update
July 25 2025
Active Locations (5)
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1
Dunamenti REK Istenhegyi IVF Center
Budapest, Budapest, Hungary, 1125
2
Dunamenti REK Gyor IVF Center
Győr, Gyor, Hungary, 9026
3
University of Pecs, Dept. OBGYN, Reproductive Center
Pécs, Pecs, Hungary, 7624
4
University of Szeged, Reproductive Medicine Institute
Szeged, Szeged, Hungary, 6723