Effect of Luteal Progesterone Support on Pregnancy Rates With Combined Clomid/ Gonadotropin & IUI
NCT ID: NCT02510534
Last Updated: 2016-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
520 participants
INTERVENTIONAL
2015-07-31
2016-04-30
Brief Summary
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Detailed Description
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Patients will be randomized in a treatment arm or control arm. The treatment arm receives the luteal progesterone support and the control arm does not. Each arm will have 260 patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
This arm receives Menopur 150 international units x 1 dose
Menopur 150 international units
Menopur 150 international units given x 1 dose
Treatment
This arm receives Menopur 150 international units x 1 dose and Endometrin 100mg twice a day x 14 days
Menopur 150 international units
Menopur 150 international units given x 1 dose
Endometrin 100 mg
Endometrin 100mg twice daily x 14 days
Interventions
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Menopur 150 international units
Menopur 150 international units given x 1 dose
Endometrin 100 mg
Endometrin 100mg twice daily x 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI 19-34 kg/m2
* Day 2-3 Follicle stimulating hormone (FSH) less than 10IU/mL
* Estradiol (E2) less than 80 pg/mL
* Anti-mullerian hormone (AMH) more than 1.5 ng/mL; or antral follicle count (AFC) up to 10
* Two patent fallopian tubes confirmed by hysterosalpingogram (HSG) or chromopertubation
* Normal uterine cavity confirmed by HSG, saline sonohysterogram (SIS) or hysteroscopy
Exclusion Criteria
* Systemic diseases not limited to diabetes
* Pregnancy within 3 months
* More than 1 prior cycle of gonadotropin treatment
* Any ovarian cyst \>15mm that has persisted for \> 1 month
* Endometrioma and/or Endometriosis-stage III or IV
* Submucosal uterine fibroids; untreated endometrial polyps \>1 cm;abnormal reproductive tract bleeding
* Intolerance or allergy to study drug
* Substance abuse (including alcohol and tobacco)
* History of chemotherapy (except for gestational conditions) or radiotherapy
* Minors and those adults not capable of consenting on their own
18 Years
37 Years
FEMALE
Yes
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Northwest Center for Infertility and Reproductive Endocrinology
OTHER
Responsible Party
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Principal Investigators
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Daniel Christie, MD
Role: PRINCIPAL_INVESTIGATOR
IVF FL
Locations
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Ivf Florida
Margate, Florida, United States
Countries
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Other Identifiers
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IVFFL001v2
Identifier Type: -
Identifier Source: org_study_id
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