Treatment Arm- Group A for Female Infertility

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Female Infertility+1 MorePregnyl (1,500) IU - Drug
Eligibility
18 - 40
Female
What conditions do you have?
Select

Study Summary

The present study aims to evaluate whether the use of a "dual trigger" can improve IVF outcomes, compared to GnRH agonist (GnRH-a) alone, in patients at high risk of OHSS undergoing a freeze-all cycle. By examining freeze-all cycles with frozen embryo transfer(s) (FET) only, we eliminate the potential confounding issue of inadequate luteal support to the endometrium and focus primarily on the effect of a "dual trigger" on oocyte quality and embryo potential. To our best knowledge, there have been no randomized, controlled trials conducted to address this hypothesis.

Eligible Conditions
  • Infertility
  • Female Infertility
  • Ovarian Hyperstimulation Syndrome

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: 2-3 days after oocyte retrieval

Day 3
Total number of mature oocytes (MII) retrieve per IVF/ICSI cycle.
Day 3
Total number of Day 3 embryos.
Week 4
Implantation rate
Day 5
Fertilization rate
Total number of fertilized zygotes.
Month 10
Live birth rate
Week 13
Clinical pregnancy rate
Pregnancy Rate
Week 2
Incidence of moderate to critical OHSS
Week 20
Miscarriage rate
Day 5
Total number of Day 5 embryos
Day 2
Total number of oocytes retrieved per cycle.

Trial Safety

Safety Progress

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

Side Effects for

Gonal-f 187.5 IU
21%Headache
13%Ovarian hyperstimulation syndrome
4%Pelvic pain
4%Anxiety
This histogram enumerates side effects from a completed 2006 Phase 4 trial (NCT00249834) in the Gonal-f 187.5 IU ARM group. Side effects include: Headache with 21%, Ovarian hyperstimulation syndrome with 13%, Pelvic pain with 4%, Anxiety with 4%.

Trial Design

2 Treatment Groups

Treatment Arm- Group A
1 of 2
Control Arm- Group B
1 of 2

Experimental Treatment

Non-Treatment Group

88 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment Arm- Group A · Has Placebo Group · Phase 4

Treatment Arm- Group A
Drug
Experimental Group · 1 Intervention: Pregnyl (1,500) IU · Intervention Types: Drug
Control Arm- Group B
Drug
PlaceboComparator Group · 1 Intervention: 1.5 mL of normal saline · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2-3 days after oocyte retrieval

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor
183 Previous Clinical Trials
64,026 Total Patients Enrolled
Miguel Russo, MDPrincipal InvestigatorMount Sinai Hospital, Canada

Eligibility Criteria

Age 18 - 40 · Female Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between the ages of 18 and 40.
You have 13 or more follicles measuring at least 11 mm on the day of trigger.
You have serum estradiol levels greater or equal to 15,000 pmol/L on the day of trigger.
References