Effect of Gonadotropin Types and Indications on Homologous Intrauterine Insemination Success (GONADOTROP)

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility

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.

• Study Type: Observational
• Enrollment (Actual): 1251

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Moncef Ben Khlifa, MD, CHU Amiens

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): November 21, 2017
• Study Completion (Actual): November 21, 2017

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: PI2017_843_0046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No