Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone

Phase 3

Recruiting

• Conditions: IVF; Embryo Loss; Luteal Phase Defect
• Interventions: Drug: Progesteron TID

• Registration Number: NCT04806919
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-19
• Study Start: 2021-04-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 242

Inclusion Criteria

• 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)

Exclusion Criteria

• 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
• Those unable to comprehend the investigational nature of the proposed study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group: Amelgen ® 400 mg TID	Progesteron TID	Increase daily progesteron dose

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	7 gestational weeks (+ or - 1 week)	visualization of an embryo with a heart beat

Secondary Outcome Measures

Name	Time	Method
Endometrial impaction: Corelation between the change in endometrial thickness on day of embryo transfer and ongoing pregnancy rate	7 gestational weeks (+ or - 1 week)

Trial Locations

Locations (2)

UZ Ghent; 🇧🇪 Ghent, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium