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

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ClinicalTrials.gov Identifier: NCT03669276
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.


Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 1251 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Effect of Gonadotropin Types and Indications on Homologous Intrauterine Insemination Success: A Study From 1251 Cycles and a Review of the Literature
Actual Study Start Date : August 1, 2014
Actual Primary Completion Date : November 21, 2017
Actual Study Completion Date : November 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility




Primary Outcome Measures :
  1. Success factors in the ovarian stimulation [ Time Frame: 7 years ]
    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.



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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes 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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669276


Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Moncef Ben Khlifa, MD CHU AMIENS
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03669276    
Other Study ID Numbers: PI2017_843_0046
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility