Does luteal support improve outcomes in modified natural-cycle frozen embryo transfer?
Official title: Is There a Need for Luteal Support in Modified Natural Cycle Frozen Embryo Transfer Cycles: a Prospective, Multicenter, Randomized Trial
Run by Dunamenti REK Istenhegyi IVF Center · NCT06875752 · Data updated 2026-11-12
This will test whether adding progesterone (with or without hCG) during a modified natural-cycle frozen embryo transfer helps people aged 18–40 with a good frozen blastocyst get pregnant.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 180 (estimated) |
| Sponsor | Dunamenti REK Istenhegyi IVF Center Academic / other |
| Locations | 5 sites (Budapest, Budapest and 4 other locations) |
| Status | Recruiting |
| Started | April 12, 2025 |
| Main results expected | April 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | July 25, 2025 |
| Trial ID | NCT06875752 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 18–40 with BMI 18–35 kg/m2, a regular 21–35 day cycle, at least one good-quality frozen blastocyst, planning a single blastocyst transfer, and an intact uterine cavity.
✕Probably not a fit
Patients unlikely to benefit include those outside the age or BMI ranges, with irregular cycles, no spontaneous dominant follicle development, recurrent miscarriage, hydrosalpinx, active HIV/hepatitis infection, or those planning multiple embryo transfers.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized controlled trial comparing three approaches for modified natural-cycle frozen embryo transfer: no luteal support, vaginal progesterone, and progesterone plus hCG. Eligible participants planning a single good-quality blastocyst transfer are randomized and undergo a modified natural FET protocol with monitoring of follicle development. Primary outcomes include implantation and clinical pregnancy rates, with follow-up for pregnancy continuation and likely live birth. The trial is conducted at several IVF centers in Hungary and uses standard inclusion/exclusion criteria to select participants.
Why it matters
Potential benefit: If successful, adding luteal support could increase implantation and live birth rates for people undergoing modified natural-cycle FET.
How similar studies have gone: Previous studies on luteal support in frozen embryo transfer have shown mixed results, with stronger evidence in stimulated or artificial cycles but inconclusive data specifically for modified natural cycles.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
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Dunamenti REK Istenhegyi IVF Center
Budapest, Budapest, Hungary Recruiting -
Dunamenti REK Gyor IVF Center
Győr, Gyor, Hungary Recruiting -
University of Pecs, Dept. OBGYN, Reproductive Center
Pécs, Pecs, Hungary Recruiting -
University of Szeged, Reproductive Medicine Institute
Szeged, Szeged, Hungary Recruiting -
Dunamenti REK Tapolca IVF Center
Tapolca, Tapolca, Hungary Recruiting
Study contacts
- Study coordinator: Peter Kovacs MD medical director Dunamenti REK Istenhegyi IVF Center, MD, PhD
- Email: peterkovacs1970@hotmail.com
- Phone: +3612022802
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Endometrial Waves and Pregnancy in FET Cycles with Hormone Therapy
This study tests whether patterns of uterine contractions during hormone-prepared frozen embryo transfer affect pregnancy outcomes.
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Comparing two vaginal progesterone forms for frozen embryo transfer
This compares whether soft vaginal progesterone capsules are easier to use, better tolerated, and give similar pregnancy results as vaginal progesterone pessaries for women having frozen embryo transfer.
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FET-LET-2x2: Testing natural vs medicated natural cycles for frozen embryo transfer
This study tests four approaches to preparing the uterus for frozen embryo transfer to see which yields the best pregnancy rate in women undergoing IVF.
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How frozen embryo transfer preparation affects uterine wave activity
We will test whether preparing for frozen embryo transfer with hormones or using a natural cycle changes uterine contractions in women having FET.
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Levothyroxine for women with mild (subclinical) hypothyroidism having IVF/ICSI and frozen embryo transfer
This project will try giving low‑dose levothyroxine to women with subclinical hypothyroidism undergoing IVF/ICSI with frozen embryo transfer to see if it improves pregnancy outcomes.
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Single-step versus multi-step blastocyst warming for frozen embryo transfer
This tests whether a simpler single-step thawing solution works as well or better than the standard multi-step warming for women having frozen blastocyst transfers.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.