Progesterone as Luteal Support in Frozen IVF Natural Cycles

NCT04725864 | Recruiting Phase 4

• 1 other identifier: 2020-005552-38
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

The ProFET study aims to investigate if luteal phase support by vaginal progesterone, is superior to no luteal phase support, in terms of live birth rate per woman after a frozen embryo transfer (FET), in a natural cycle (NC) after in-vitro fertilization (IVF), and if 7 weeks of treatment is superior to 3 weeks duration.

Conditions

Infertility; Embryo Transfer

Keywords

progesterone; luteal phase support; frozen embryo transfer; natural cycles; live birth

Outcome Measures

Primary Outcomes (1)

• Number of participants with live birth

  A child born alive. Also, the outcome will be reported according to Core Outcome Measure for Infertility Trials (Duffy et al., 2020) in a separate appendix.

  Up to 41 weeks after embryo transfer.

Secondary Outcomes (26)

• Number of participants with biochemical pregnancy

  2-3 weeks after embryo transfer.

• Number of participants with clinical pregnancy

  4-8 weeks after embryo transfer.

• Number of participants with ongoing pregnancy

  5-7 weeks after embryo transfer.

• Number of participants with miscarriage

  Up to 20 weeks after embryo transfer.

• Number of participants with ectopic pregnancy

  Up to 20 weeks after embryo transfer.

Study Arms (3)

No progesterone

NO INTERVENTION

Patients will have FET in natural cycles with no extra intervention.

Progesterone for 3 weeks

EXPERIMENTAL

At day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for three weeks.

Drug: Progesterone vaginal tablet

Progesterone for 7 weeks

EXPERIMENTAL

At day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for seven weeks.

Drug: Progesterone vaginal tablet

Interventions

Progesterone vaginal tablet DRUG

The study drug is progesterone 100 mg administrated as a vaginal tablet three times daily.

Also known as: Lutinus, manufactured by Ferring GmbH. ATC code G03DA04

Progesterone for 3 weeks; Progesterone for 7 weeks

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Planned for a FET-NC with a blastocyst
• BMI \>18.5 \<35
• Regular menstrual cycles 24-35 days
• Given informed consent
• Understand written and spoken Swedish, English or Arabic

You may not qualify if:

• Oocyte donor cycles, preimplantation genetic testing (PGT) cycles. Uterine malformation, submucous myoma and endometrial polyps.
• Hypersensitivity against study medication. Other contraindications according to www.fass.se
• Development of serious disease contraindicating ART or pregnancy.
• Participation or recent participation in a clinical study with an investigational product (past 30 days). Previous participation in this study.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (1)

Department of Reproductive Medicine

Gothenburg, S-41345, Sweden

RECRUITING

Related Publications (2)

• Duffy JMN, AlAhwany H, Bhattacharya S, Collura B, Curtis C, Evers JLH, Farquharson RG, Franik S, Giudice LC, Khalaf Y, Knijnenburg JML, Leeners B, Legro RS, Lensen S, Vazquez-Niebla JC, Mavrelos D, Mol BWJ, Niederberger C, Ng EHY, Otter AS, Puscasiu L, Rautakallio-Hokkanen S, Repping S, Sarris I, Simpson JL, Strandell A, Strawbridge C, Torrance HL, Vail A, van Wely M, Vercoe MA, Vuong NL, Wang AY, Wang R, Wilkinson J, Youssef MA, Farquhar CM; Core Outcome Measure for Infertility Trials (COMMIT) initiative. Developing a core outcome set for future infertility research: an international consensus development studydagger double dagger. Hum Reprod. 2020 Dec 1;35(12):2725-2734. doi: 10.1093/humrep/deaa241.

  PMID: 33252685 RESULT

• Stadelmann C, Bergh C, Brannstrom M, Olsen KH, Khatibi A, Kitlinski M, Liffner S, Lundborg E, Rodriguez-Wallberg KA, Strandell A, Westlander G, Widlund G, Magnusson A. Vaginal progesterone as luteal phase support in natural cycle frozen-thawed embryo transfer (ProFET): protocol for a multicentre, open-label, randomised controlled trial. BMJ Open. 2022 Jul 8;12(7):e062400. doi: 10.1136/bmjopen-2022-062400.

  PMID: 35803628 DERIVED

Related Links

• EUROCAT classification system

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Åsa Magnusson, MD, PhD

  Vastra Gotaland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Åsa Magnusson, MD, PhD

CONTACT

+46 70-265 55 85; asa.magnusson@vgregion.se

Caroline Stadelmann, MD

CONTACT

+46 73-903 14 13; caroline.stadelmann@vgregion.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Two main arms, of which the experimental arm is split in two arms with different duration of treatment

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 27, 2021
• Study Start: May 1, 2021
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)