Clinical trial Recruiting at 5 sites Phase 4 Interventional Ages 18 to 40 Women only

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

PhasePhase 4
Study typeInterventional
Ages18 Years to 40 Years
SexWomen only
Enrollment180 (estimated)
SponsorDunamenti REK Istenhegyi IVF Center
Academic / other
Locations5 sites (Budapest, Budapest and 4 other locations)
StatusRecruiting
StartedApril 12, 2025
Main results expectedApril 1, 2026
Study endsDecember 1, 2026
Registry record updatedJuly 25, 2025
Trial IDNCT06875752 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.