HCG Versus Spontaneous LH in Intrauterine Insemination (IUI ) Cycles

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Spontaneous Triggering of Ovulation vs. Administration of Human Chorionic Gonadotropin in Patients Undergoing IUI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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spontaneous LH

Group Type OTHER

HCG

Intervention Type DRUG

5000 IU

HCG

Group Type EXPERIMENTAL

HCG

Intervention Type DRUG

5000 IU

Interventions

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HCG

5000 IU

Intervention Type DRUG

Eligibility Criteria

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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).