Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer Cycles

NCT04758871 | Completed Phase 4 DMC

• 1 other identifier: REMODEL
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the efficacy of dydrogesterone 30 mg compared to micronized vaginal progesterone 800 mg daily for luteal phase support in hormone replacement therapy frozen embryo transfer cycles, as confirmed by visualization of fetal heart activity by pelvic ultrasound assessment of ongoing pregnancy at 12 weeks of gestation.

Conditions

Frozen Embryo Transfer; Hormone Replacement Therapy; Dydrogesterone; Infertility, Female

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy

  visualisation of a fetal heart activity via pelvic (vaginal/abdominal) ultrasound examination at 12 weeks of gestation.

  12 weeks

Secondary Outcomes (15)

• Live birth rate

  22-42 weeks

• Time of delivery

  follow-up time of 30 days after delivery

• Incidence of Treatment-Emergent Adverse Events

  follow-up time of 30 days after delivery

• Patient reported outcome

  day 12-18 of luteal phase supplementation (pregnancy test) and at 12 weeks gestation

• Incidence of newborn adverse events

  follow-up time of 30 days after delivery

Study Arms (2)

Dydrogesterone

EXPERIMENTAL

Luteal phase support for hormone replacement therapy frozen embryo transfer cycles using dydrogesterone 10 mg 3 times daily

Drug: Dydrogesterone 10 MG Oral Tablet

Micronized progesterone

ACTIVE COMPARATOR

Luteal phase support for hormone replacement therapy frozen embryo transfer cycles using micronized progesterone 2x200 mg twice daily vaginally

Drug: Micronized progesterone

Interventions

Dydrogesterone 10 MG Oral Tablet DRUG

10 mg three times daily

Dydrogesterone

Micronized progesterone DRUG

2x 200 mg vaginal tablets two times daily

Micronized progesterone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≤40 years of age at the time of IVF/ICSI treatment
• BMI ≥18 to ≤30 kg/m2 with a documented history of infertility
• Have undergone COS as part of an ART treatment and have had an unsuccessful fresh embryo transfer in that cycle, OR, have undergone freeze all strategy
• Scheduled to undergo FET with a standard exogenous/programmed hormonal replacement therapy (HRT) regimen
• Have at least 1 blastocyst vitrified on the 5th or 6th day after oocyte retrieval
• Elective single embryo (blastocyst) transfer (SET)
• Normal ultrasound examination at enrollment (or if \<12 months old)
• Signed patient authorization for use/disclosure of data.

You may not qualify if:

• Women with a history of recurrent miscarriage, defined as \>2 consecutive miscarriages (biochemical pregnancy losses are not included)
• Absence of implantation (serum hCG = negative) after two consecutive cycles of IVF, ICSI or FET where the cumulative number of transferred embryos was \>4 cleavage-stage embryos and \>2 blastocysts
• Presence of hydrosalpinx that is not surgically treated
• Endometrial abnormalities on scanning during ovarian stimulation, such as endometrial polyp(s), sub mucosal fibroid(s), endometrial hyperplasia, endometrial fluid accumulation, or endometrial adhesions
• Participating in another clinical study at the same time
• Known allergic reactions to dydrogesterone or other progestogens products
• Any contraindication or other condition that precludes use of dydrogesterone in a particular patient, in accordance with the precautions listed in the locally approved label
• Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subjects in or to complete the study
• History of prior chemotherapy
• Contraindication for pregnancy
• Transfer of \>1 embryo

Sponsors & Collaborators

• CRG UZ Brussel: lead

Study Sites (1)

Brussels IVF

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Dydrogesterone; Tablets; Progesterone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Pregnenediones; Pregnenes; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Christophe Blockeel

  CRG UZ Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-investigator

Model Details: Open label randomized controlled trial

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 17, 2021
• Study Start: October 1, 2021
• Primary Completion: September 11, 2023
• Study Completion: June 13, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)