Investigational for Infertility

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Infertility
Progesterone-IBSA Injectable Solution - Drug
Eligibility
18 - 65
Female
What conditions do you have?
Select

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

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: from 5 weeks post embryo transfer until the 12th week of pregnancy.

10 weeks post-embryo transfer
Ongoing pregnancy
Day 2
Positive pregnancy rate
Week 4
Adverse events related to the newborn.
Week 4
Delivery rate
Live birth rate
Day 4
Progesterone
5 weeks post-embryo transfer
Clinical pregnancy rate
Week 6
Implantation rate
after the 12th week of pregnancy until delivery.
Late miscarriage rate
Week 5
Early Miscarriage rate
Ectopic pregnancy rate
Week 4
Adverse Events related to the mother
Week 10
Local tolerability
Week 10
Cycle cancellation rate (with reason)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

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

InvestigationalExperimental Group · 2 Interventions: Placebo Vaginal gel with applicator, Progesterone-IBSA Injectable Solution · Intervention Types: Drug, Drug
ComparatorActiveComparator Group · 2 Interventions: Progesterone Vaginal Gel with Applicator, Placebo injectable solution · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from 5 weeks post embryo transfer until the 12th week of pregnancy.

Who is running the clinical trial?

IBSA Institut Biochimique SALead Sponsor
34 Previous Clinical Trials
9,938 Total Patients Enrolled
10 Trials studying Infertility
3,969 Patients Enrolled for Infertility

Eligibility Criteria

Age 18 - 65 · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Semen used during IVF was produced by ejaculation (not surgically derived sperm) from either the partner or from a sperm donor.
You are 35 to 42 years of age at the time of consent.
You have regular, spontaneous ovulatory menstrual cycles with normal length.

About The Reviewer

Michael Gill preview

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?
California100.0%
What site did they apply to?
Kindbody100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
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?
1100.0%