Study Summary
This is a multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority clinical study in women aged 35 to 42 years. This study will investigate the safety and efficacy of Progesterone-IBSA to support euploid embryo blastocyst implantation and early pregnancy after frozen embryo transfer (FET) in a modified natural cycle as a treatment for infertile women. Subjects will be randomized to receive either active Progesterone-IBSA or Crinone 8% for luteal and early pregnancy support and these two groups will be compared.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 11 Secondary · Reporting Duration: from 5 weeks post embryo transfer until the 12th week of pregnancy.
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Comparator
1 of 2
Investigational
1 of 2
Active Control
Experimental Treatment
680 Total Participants · 2 Treatment Groups
Primary Treatment: Investigational · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 65 · Female Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:About The Reviewer
Michael Gill - B. Sc.
First Published: October 11th, 2021
Last Reviewed: November 2nd, 2022
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| California | 100.0% |
What site did they apply to?
| Kindbody | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Why did patients apply to this trial?
- "My husband and I had a ectopic pregnancy and we don’t know why. I was told that this is the first tome they have ever saw and ectopic abort itself without meds, surgery or patient dying"
How many prior treatments have patients received?
| 1 | 100.0% |