Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone

IVF Clinical Trial

— PROTECTA  

Official title:

Randomized Controlled Trial Comparing Micronized Progesterone (Amelgen ®) 400 mg BID Versus 400 mg TID for Luteal Support in Artificial Vitrified/Warmed Single Blastocyst Transfer Cycles With Low Progesterone on Day of Embryo Transfer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04806919
• Other study ID #: 2020-004112-10
• Status: Recruiting
• Phase: Phase 3
• Start date: April 2, 2021
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Embryo Loss
• IVF
• Luteal Phase Defect

Intervention

Drug:
• Progesteron TID
increasing the dose

Locations

Country	Name	City	State
Belgium	UZ Ghent	Ghent
Belgium	AZ Delta	Roeselare

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Questionnaire on patient comfort and side effects		On the day of embryo transfer (day 5)
Other	Questionnaire on patient comfort and side effects		On the day of the initial pregnancy test (day 16 (± 2 days))
Primary	Ongoing pregnancy rate	visualization of an embryo with a heart beat	7 gestational weeks (+ or - 1 week)
Secondary	Endometrial impaction: Corelation between the change in endometrial thickness on day of embryo transfer and ongoing pregnancy rate		7 gestational weeks (+ or - 1 week)