Infertility Clinical Trial
— GONADOTROPOfficial title:
Effect of Gonadotropin Types and Indications on Homologous Intrauterine Insemination Success: A Study From 1251 Cycles and a Review of the Literature
Verified date | August 2018 |
Source | Centre Hospitalier Universitaire, Amiens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1251 |
Est. completion date | November 21, 2017 |
Est. primary completion date | November 21, 2017 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 20 Years to 44 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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