Effect of Gonadotropin Types and Indications on Homologous Intrauterine Insemination Success

NCT03669276 | Completed

• 1 other identifier: PI2017_843_0046
• Study Type: observational
• Target: 1,251
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Success factors in the ovarian stimulation

  The 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.

  7 years

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All couples attending our reproductive medical center to obtain homologous IUI program with COS between January 2007 and August 2014 ll 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Moncef Ben Khlifa, MD

  CHU AMIENS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: September 13, 2018
• Study Start: August 1, 2014
• Primary Completion: November 21, 2017
• Study Completion: November 21, 2017
• Last Updated: September 18, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share