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Effect of Gonadotropin Types and Indications on Homologous Intrauterine Insemination Success

Effect of Gonadotropin Types and Indications on Homologous Intrauterine Insemination Success: A Study From 1251 Cycles and a Review of the Literature

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03669276
Acronym
GONADOTROP
Enrollment
1251
Registered
2018-09-13
Start date
2014-08-01
Completion date
2017-11-21
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 44 Years

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)

Design outcomes

Primary

MeasureTime frameDescription
Success factors in the ovarian stimulation7 yearsThe objective of this study is to evaluate the level of success factors of intrauterine insemination (IUI) in controlled ovarian stimulation (COS) in order to define the type of infertility. This retrospective cohort study included 1251 couples undergoing homologous IUIs.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMoncef BEN KHALIFA, PU-PH

CHU AMIENS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026