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NCT Number: NCT05899010

MIcronized PROgesterone in Frozen Embryo Transfer Cycles

This randomized trial was designed as non-inferiority trial aiming to compare ongoing pregnancy rates following LPS with 600 mg/day vs 800 mg/day vaginal VMP. All patients will undergo an artificial cycle frozen embryo transfer (AC-FET) with transdermal estradiol 6mg/day Patients undergoing an artificial cycle FET will start estrogen priming with transdermal estradiol 6mg/day (Estrogel®) on cycle D1-D3. Following 10-12 days of estrogen priming, patients will be randomized to luteal phase support with a standard formulation (200mg tid, Utrogestan®) or a new formulation (400mg bid) VMP. All patients will undergo a serum P measurement on the day before embryo transfer (ET). Patients with P<10 ng/ml will receive a supplement of oral micronized progesterone 300mg, while patients with P≥10ng/ml will maintain the previous luteal phase support (LPS) protocol

Recruiting

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Quiron Dexeus

Barcelona, 08028, Spain

Location status: Recruiting

Location contact

Nikolaos P Polyzos, MD PhD

CONTACT

[email protected]

0034932274700

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Endometrial preparation with hormone replacement therapy
  • Age 18-43 years following an autologous IVF cycle (with or without preimplantation genetic testing for aneuploidy)
  • Age < 50 years following an egg donation cycle
  • BMI > 18 and < 30 kg/m2
  • blastocyst embryo transfer
  • Willing to participate in the study
  • Able to come to the Center to comply with the procedures of the study: blood tests, appointments and drug dispensation.

Exlusion Criteria:

  • • Uterine diseases (e.g. submucosal fibroids, polyps, previously diagnosed Müllerian abnormalities)
  • Hydrosalpinx
  • Recurrent pregnancy loss (≥ 3 previous miscarriages)
  • Recurrent implantation failure (≥ 3 previously failed embryo transfers of good-quality blastocysts)
  • Allergy to study medication
  • Pregnancy or lactation
  • Contraindication for hormonal treatment
  • Personalized initiation of exogenous progesterone according to a previous endometrial receptivity assay test
  • Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfere with the trial assessment).

Treatment and study plan

Vaginal progesterone 600mg daily

Drug

If endometrial thickness (ETH) ≥7 mm and follicle dominance/ultrasound (US) signs of ovulation P levels are measured: if P ≤1.5 patients start LPS, else cycle is cancelled. If ETH <7mm and no follicle dominance: estradiol dose is increased to 9mg/day and new US is performed up to 4 days after. If persistent thin endometrium after dose increase, cycle is cancelled. 24-48h pre ET, E2 and P are measured. in the morning, pre VMP dose, or at least 6h after last progesterone dose. If progesterone <10ng/ml, additional 300mg daily oral micronized progesterone is administered on the day of the ET and maintained until 10 weeks pregnancy or up to menses or up to negative pregnancy test 10 days after ET. ET will be performed with available blastocysts 6 days after start of LPS. 3-5 days, after ET, a blood test for P measurement will be performed in the morning, before VMP dose, or at least 6h after last progesterone dose. 10 days after ET, the last P test will be done with pregnancy test.

Vaginal progesterone 800mg daily

Drug

If endometrial thickness (ETH) ≥7 mm and follicle dominance/ultrasound (US) signs of ovulation P levels are measured: if P ≤1.5 patients start LPS, else cycle is cancelled. If ETH <7mm and no follicle dominance: estradiol dose is increased to 9mg/day and new US is performed up to 4 days after. If persistent thin endometrium after dose increase, cycle is cancelled. 24-48h pre ET, E2 and P are measured. in the morning, pre VMP dose, or at least 6h after last progesterone dose. If progesterone <10ng/ml, additional 300mg daily oral micronized progesterone is administered on the day of the ET and maintained until 10 weeks pregnancy or up to menses or up to negative pregnancy test 10 days after ET. ET will be performed with available blastocysts 6 days after start of LPS. 3-5 days, after ET, a blood test for P measurement will be performed in the morning, before VMP dose, or at least 6h after last progesterone dose. 10 days after ET, the last P test will be done with pregnancy test.

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: 7-9 weeks after embryo transfer

    A positive heart beat at ultrasound after 11-13 weeks of gestation

Secondary outcomes

  1. Implantation rate

    Time frame: 3-4 weeks after embryo transfer

    Number of gestational sacs over total embryo transfered

  2. Biochemical pregnancy rate

    Time frame: 10 to 12 days after embryo transfer

    positive beta-human chorionic gonadotropin (hCG)

  3. Clinical pregnancy rate

    Time frame: 3-4 weeks after embryo transfer

    A positive heart beat at ultrasound

  4. Miscarriage rate

    Time frame: before completion of 12 weeks of gestation

    any spontaneous abortion that occurred after confirmation of clinical pregnancy

  5. Frequency of adverse events

    Time frame: Until 15 days after the end of treatment with progesterone

Study contacts

Contact information is provided by the study sponsor or research team.

Ignacio Rodríguez, MSc

CONTACT

[email protected]

0034932274700

Nikolaos P Polyzos, MD, PhD

CONTACT

[email protected]

0034932274700

Sponsors and collaborators

Lead sponsor

Fundación Santiago Dexeus Font

Other

Registry information

Official study title

A Phase III Randomized Controlled Trial Comparing the Efficacy, Safety and Tolerability of Two Formulations of Vaginal Micronized Progesterone

Acronym: MI-PROF

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jun 12, 2023
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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