Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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IVF, Embryo Loss, Luteal Phase Defect

Intervention / Treatment
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* Drug: Progesteron TID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group: Amelgen ® 400 mg BID<br>Continue daily dose progesteron | |
| Experimental: Intervention group: Amelgen ® 400 mg TID<br>Increase daily progesteron dose | Drug: Progesteron TID<br>* increasing the dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate | visualization of an embryo with a heart beat | 7 gestational weeks (+ or - 1 week) | 

Secondary Outcome Measures

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