HCG Versus Spontaneous LH in Intrauterine Insemination (IUI ) Cycles

Universitair Ziekenhuis Brussel

Status and phase: Completed; Early Phase 1

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

Treatments: Drug: HCG

Study type: Interventional

Funder types: Other

Identifiers

NCT01414673

WAS11

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: Accepts Healthy Volunteers

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

• PCOS
• endometriosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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300 participants in 2 patient groups

spontaneous LH

Other group

Treatment:

Drug: HCG

HCG

Experimental group

Treatment:

Drug: HCG