Effect of Gonadotropin Types and Indications on Homologous Intrauterine Insemination Success

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1251 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-01

Study Completion Date

2017-11-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this study the investigators took the opportunity of having a large sample of IUI cycles in a single centre to try to analyse the effect of stimulation protocols and of the infertility origin on the results, taking in account the main confounding variables (female age, IUI attempt rank, and sperm quality) on the clinical outcome.

All couples had undergone a standard infertility evaluation, which included medical history, physical examination, and assessment of tubal patency by either hysterosalpingography or laparoscopy and hormonal analysis on cycle day 3. A transvaginal ultrasound scan was performed on the second day of the cycle. On the same day, ovarian stimulation was carried out with recombinant FSH (follitropinrFSH; Gonal-F, MerckSerono, France, orfollitropin;Puregon, MSD, France), urinary FSH (urofollitropin, Fostimon, France), orhMG (menotropin, Menopur, France) atastarting dose of 75 IU/day from the second day of the cycle.

The main clinical outcome measures were clinical pregnancy and live-birth rates per cycle. Clinical pregnancy was defined as the evidence of pregnancy by ultrasound examination of the gestational sac at weeks 5-7.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Observation of the Response to Ovulation Triggering on the Day of Intrauterine Insemination and Correlation Between Progesterone Level and Pregnancy Rate (OVUL-IIU)

NCT07038616

Infertility

COMPLETED

Only Gonadotropin Vs. Letrozole Combined Gonadotropin Stimulation in IUI Cycles

NCT06413771

Infertility Unexplained

COMPLETED NA

Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation

NCT01044862

Pregnancy Unexplained Infertility

COMPLETED PHASE3

HCG Versus Spontaneous LH in Intrauterine Insemination (IUI ) Cycles

NCT01414673

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

COMPLETED EARLY_PHASE1

Comparison of Recombinant Follicle Stimulating Hormone and the Combination of Recombinant Follicle Stimulating Hormone With Clomiphene Citrate in Stimulated Intrauterine Insemination Cycles

NCT05670795

Infertility Unexplained

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Many studies have evaluated the predictive factors of IUI clinical outcomes, including the female's age, the infertility duration, the rank of the attempt, and the sperm parameters \[10-16\]. However, few studies have compared the pregnancy rates based on the used COS or on the infertility type.

In this study the investigators took the opportunity of having a large sample of IUI cycles in a single centre to try to analyse the effect of stimulation protocols and of the infertility origin on the results, taking in account the main confounding variables (female age, IUI attempt rank, and sperm quality) on the clinical outcome.

All couples had undergone a standard infertility evaluation, which included medical history, physical examination, and assessment of tubal patency by either hysterosalpingography or laparoscopy and hormonal analysis on cycle day 3. A transvaginal ultrasound scan was performed on the second day of the cycle. On the same day, ovarian stimulation was carried out with recombinant FSH (follitropinrFSH; Gonal-F, MerckSerono, France, orfollitropin;Puregon, MSD, France), urinary FSH (urofollitropin, Fostimon, France), orhMG (menotropin, Menopur, France) atastarting dose of 75 IU/day from the second day of the cycle.

The main clinical outcome measures were clinical pregnancy and live-birth rates per cycle. Clinical pregnancy was defined as the evidence of pregnancy by ultrasound examination of the gestational sac at weeks 5-7.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* women with a failure to conceive after, ≥12 months of unprotected and regular intercourse,
* aged 20-44 years
* with normal ovulation reserve (basal follicle- stimulating hormone (FSH) level \< 10 IU/l and estradiol (E2) level \< 30ng/mL);
* theirpartnershadtohaveatotal motile sperm (TMS) count of\>1×106.

Exclusion Criteria

* TMS ≤1×106;
* sperm donation;
* seropositivity for human immunodeficiency virus (HIV) for any couple member;
* inseminations performed in a natural cycle or with clomiphene citrate (CC)

Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No