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IUI Schedule in Cases of High Progesterone

Programming IUI With Sperm Donor in Patients With High Progesterone the Day of hCG Administration

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02447588
Acronym
IAD-P4
Enrollment
70
Registered
2015-05-19
Start date
2015-07-31
Completion date
2016-10-31
Last updated
2015-05-19

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

Conditions

Infertility

Keywords

intrauterine insemination, progesterone

Brief summary

Intrauterine insemination (IUI) combined with ovarian stimulation protocols has become one of the first alternative treatment against infertility, although results in gestational terms are highly variable, ranging between 10% and 25%. The influence of progesterone levels in stimulated cycles of intrauterine insemination is an aspect little studied; however, this information may be useful when synchronizing the time of insemination with the implantation window, as it has been observed that patients with elevated levels of progesterone in the follicular phase exhibit a significant decrease in ongoing pregnancy rates, these results being possible due to premature ovulation which causes asynchrony between the embryo and the endometrium. Taking into account these considerations, the aim of the investigators' study is to determine the effectiveness, in terms of ongoing pregnancy rates, to advance the intrauterine insemination with sperm donor (24 hours post-hCG) with respect to the standard schedule (36 hours post-hCG) according progesterone levels determined the day of hCG administration

Detailed description

Correct schedule of intrauterine insemination is essential to the success of these treatments due to the limited range in which the capacitated sperm survive the female genital tract and oocytes can be fertilized after ovulation. For intrauterine insemination, the fraction of motile sperm is injected directly into the uterine cavity and later migrate into abdominal cavity, where they remain a few hours after insemination; meanwhile, fertilizable oocytes are only between 12-16 hours after ovulation. In the cycles in which follicular growth is monitored, a spontaneous LH surge before ovulation induction with HCG is a possibility; indeed, in stimulated cycles LH is not usually determined so clinicians are not able to know if there has been or not ovulation. Ovulation usually occurs 24 hours after the LH surge; therefore, an insemination performed 36 hours after ovulation induction may be too late in cases of premature ovulation. The influence of progesterone levels in stimulated cycles of intrauterine insemination is an aspect little studied; however, this information can be useful when synchronizing the time of insemination with the implantation window. The day of ovulation induction, the investigators will determine progesterone levels. If progesterone\> 1 ng / ml the patient be randomized in one of the following groups: * Group 1 (intrauterine insemination with sperm donor IAD at 36 hours post-hCG). Cases where the IAD is scheduled at 36 hours post-administration of hCG. * Group 2 (IAD at 24 hours post-hCG). Cases where the IAD is scheduled at 24 hours post-administration of hCG.

Interventions

OTHERIAD at 36 hours

Intrauterine insemination with sperm donor at 36 hours post-hCG

OTHERIAD at 24 hours

Intrauterine insemination with sperm donor at 24 hours post-hCG

Sponsors

Vida Recoletas Sevilla
CollaboratorOTHER
IVI Vigo
CollaboratorOTHER
IVI Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Body mass index (BMI) 18-30 kg / m2 * Patent tubes * Regular cycles (26-35 days) * FSH levels on day 3 of cycle (\<10 mIU / ml) * Estradiol levels on day 3 of cycle (\<60 pg / ml) * Progesterone levels the day of hCG (\> 1 ng / ml) * Semen donors belonging to the bank of IVI

Exclusion criteria

* Patients with ≥3 follicles of over 16 mm diameter * No dominant follicle after two consecutive ultrasound * Women with P \<1 ng / ml on the day of hCG

Design outcomes

Primary

MeasureTime frame
Ongoing pregnancy rate1 month

Secondary

MeasureTime frame
Estradiol levels the day of hCG administration1 day
LH levels the day of hCG administration1 day
Days of stimulation1 day
Doses of gonadotropins1 day
Pregnancy rate1 month
Miscarriage rate1 month
Cancellation rate1 month

Contacts

Primary ContactAntonio Requena, PhD, MD
Antonio.Requena@ivi.es911802900
Backup ContactMaria Cruz, PhD
Maria.Cruz@ivi.es911802900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026