NCT01414673CompletedEarly Phase 1
Spontaneous Triggering of Ovulation vs. Administration of Human Chorionic Gonadotropin in Patients Undergoing Intrauterine Insemination: a Prospective Randomized Study.
Universitair Ziekenhuis Brussel1 site in 1 country300 target enrollmentStarted: April 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- ongoing pregnancy rate
Study Overview
Brief Summary
We recently reported the superiority of the natural cycle to a natural cycle controlled by the administration of human chorionic gonadotropin (hCG) for planning the frozen-thawed embryo transfer cycles, demonstrating a probable negative impact of exogenous hCG on endometrial receptivity.Based on the above findings we conducted the first prospective study that assesses whether there is a difference in pregnancy rate after intrauterine insemination (IUI) in a natural cycle with spontaneous luteinizing hormone (LH) rise compared to natural cycles controlled by hCG for final ovulation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 36 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age ≤ 36 years,
- •regular menstrual cycles,
- •body mass index (BMI) between 18 and 29 kg/m²,
- •basal levels of FSH (≤ 12 IU/l),
- •estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle, normal hysterosalpingography (maximum 3 months prior starting the cycle).
- •The use of donor sperm was also accepted as inclusion criteria.
Exclusion Criteria
- •endometriosis
Arms & Interventions
spontaneous LH
Other
Intervention: HCG (Drug)
HCG
Experimental
Intervention: HCG (Drug)
Outcomes
Primary Outcomes
ongoing pregnancy rate
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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