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Anti-estrogen
Clomid Protocols for Female Infertility
Phase 4
Waitlist Available
Led By Richard Paulson
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diminished ovarian reserve
Prior poor response to ovarian stimulation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 month after study completion
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial compares a longer Clomid treatment with a shorter 5-day Clomid treatment for women with low ovarian reserve who are undergoing IVF or egg freezing. The longer treatment aims to stimulate the ovar
Who is the study for?
This trial is for women with reduced ovarian function who are undergoing IVF or egg freezing. They should not have participated in similar studies before and must be able to follow the protocol, which includes taking medication and attending follow-up appointments.
What is being tested?
The study compares a long Clomid (Clomiphene Citrate) protocol against a standard short one for ovarian stimulation. The goal is to see if the longer treatment leads to more eggs being retrieved while reducing costs and injections needed.
What are the potential side effects?
Possible side effects of Clomid include hot flashes, abdominal discomfort, bloating, breast tenderness, nausea, headache, visual disturbances, and rarely an increased risk of multiple pregnancies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ovarian reserve is low.
Select...
I have had a poor response to fertility treatments before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 month after study completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 month after study completion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of mature oocytes
Secondary study objectives
Number of oocytes that get fertilized and grow to the blastocyst stage
Number of participants that experience premature ovulation
Pregnancy outcomes
Side effects data
From 2014 Phase 3 trial • 900 Patients • NCT0104486230%
Headache
27%
Abdominal Bloating
22%
Breast Pain
11%
Injection Site Reaction
8%
Hot Flashes
4%
Ectopic pregnancy
2%
Constipation
2%
Joint/Limb pain
1%
Congenital anomaly
1%
Hyperemesis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Follicle Stimulating Hormone (FSH)
Clomiphene Citrate (CC)
Aromatase Inhibitors (AI)
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Long ClomidExperimental Treatment1 Intervention
Clomid with gonadotropins throughout the entire duration of ovarian stimulation without addition of GnRH antagonist
Group II: 5-day ClomidActive Control1 Intervention
Clomid only for 5 days starting on day 2 or 3 of menses with gonadotropins, with GnRH antagonist added when the lead follicle reaches \~14mm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clomiphene Citrate
2019
Completed Phase 4
~1850
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
946 Previous Clinical Trials
1,604,559 Total Patients Enrolled
Richard PaulsonPrincipal Investigatorrpaulson@med.usc.edu