Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone

NCT04806919 | Completed Phase 3

• 1 other identifier: 2020-004112-10
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 2

Brief Summary

The study aims to evaluate the effect of an increased dose of vaginal progesterone supplementation on the incidence of ongoing pregnancy for patients with a suboptimal serum progesterone level (defined as \< 10 mcg/l) on the day of blastocyst transfer.

Conditions

Luteal Phase Defect; IVF; Embryo Loss

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

  visualization of an embryo with a heart beat

  7 gestational weeks (+ or - 1 week)

Secondary Outcomes (1)

• Endometrial impaction: Corelation between the change in endometrial thickness on day of embryo transfer and ongoing pregnancy rate

  7 gestational weeks (+ or - 1 week)

Other Outcomes (2)

• Questionnaire on patient comfort and side effects

  On the day of embryo transfer (day 5)

• Questionnaire on patient comfort and side effects

  On the day of the initial pregnancy test (day 16 (± 2 days))

Study Arms (2)

Control group: Amelgen ® 400 mg BID

NO INTERVENTION

Continue daily dose progesteron

Intervention group: Amelgen ® 400 mg TID

EXPERIMENTAL

Increase daily progesteron dose

Drug: Progesteron TID

Interventions

Progesteron TID DRUG

increasing the dose

Intervention group: Amelgen ® 400 mg TID

Eligibility Criteria

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

You may qualify if:

• Informed consent form (ICF) dated and signed
• Age ≥ 18 and \< 43 years old
• Body Mass Index (BMI) ≥ 18.5 kg/m2 and \< 35 kg/m2
• Less than 4 previous Assisted Reproductive Technologies (ART) cycles
• Current pregnancy wish
• Patients undergoing a single vitrified/warmed single transfer in an artificial prepared endometrium cycle (IVF or ICSI)

You may not qualify if:

• Simultaneous participation in another clinical study
• Previous participation in this study
• Known reasons for impaired implantation (specifically: presence of a hydrosalpinx; presence of a type I, II or III fibroid; Asherman's syndrome; uterine malformations, intrauterine adhesions, ≥ grade 3 endometriosis according to the ASRM classification, endometrial tuberculosis)
• Repeated miscarriages (\> 2 miscarriages)
• Untreated and uncontrolled thyroid dysfunction
• Tumors of the ovary, breast, uterus, pituitary or hypothalamus
• Abnormal vaginal bleeding without a known/diagnosed cause
• Ovarian cysts or enlarged ovaries
• Fibroid tumors of the uterus incompatible with pregnancy
• Malformations of the reproductive organs incompatible with pregnancy
• Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin)
• Risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia
• Active smoking
• Ongoing pregnancy
• Use of carbamazepine, rifampicin or phenytoin

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (2)

UZ Ghent

Ghent, 9000, Belgium

Location

AZ Delta

Roeselare, Belgium

Location

MeSH Terms

Conditions

Embryo Loss

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: March 19, 2021
• Study Start: April 2, 2021
• Primary Completion: February 28, 2025
• Study Completion: March 31, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)