NCT02447588

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

May 7, 2015

Last Update Submit

May 14, 2015

Conditions

Infertility

Keywords

intrauterine inseminationprogesterone

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    1 month

Secondary Outcomes (7)

  • Doses of gonadotropins

    1 day

  • Estradiol levels the day of hCG administration

    1 day

  • LH levels the day of hCG administration

    1 day

  • Days of stimulation

    1 day

  • Cancellation rate

    1 month

  • +2 more secondary outcomes

Study Arms (2)

Group 1

OTHER

Intrauterine insemination with sperm donor (IAD) at 36 hours post-hCG. Cases where the IAD is scheduled at 36 hours post-administration of hCG.

Other: IAD at 36 hours

Group 2

EXPERIMENTAL

Intrauterine insemination with sperm donor (IAD) at 24 hours post-hCG. Cases where the IAD is scheduled at 24 hours post-administration of hCG.

Other: IAD at 24 hours

Interventions

IAD at 36 hoursOTHER

Intrauterine insemination with sperm donor at 36 hours post-hCG

Group 1
IAD at 24 hoursOTHER

Intrauterine insemination with sperm donor at 24 hours post-hCG

Group 2

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Venetis CA, Kolibianakis EM, Papanikolaou E, Bontis J, Devroey P, Tarlatzis BC. Is progesterone elevation on the day of human chorionic gonadotrophin administration associated with the probability of pregnancy in in vitro fertilization? A systematic review and meta-analysis. Hum Reprod Update. 2007 Jul-Aug;13(4):343-55. doi: 10.1093/humupd/dmm007. Epub 2007 Apr 3.

    PMID: 17405832BACKGROUND

  • Antaki R, Dean NL, Lapensee L, Racicot MH, Menard S, Kadoch IJ. An algorithm combining ultrasound monitoring and urinary luteinizing hormone testing: a novel approach for intrauterine insemination timing. J Obstet Gynaecol Can. 2011 Dec;33(12):1248-52. doi: 10.1016/s1701-2163(16)35110-6.

    PMID: 22166279RESULT

  • Azem F, Tal G, Lessing JB, Malcov M, Ben-Yosef D, Almog B, Amit A. Does high serum progesterone level on the day of human chorionic gonadotropin administration affect pregnancy rate after intracytoplasmic sperm injection and embryo transfer? Gynecol Endocrinol. 2008 Jul;24(7):368-72. doi: 10.1080/09513590802196353.

    PMID: 18645708RESULT

  • Blockeel C, Knez J, Polyzos NP, De Vos M, Camus M, Tournaye H. Should an intrauterine insemination with donor semen be performed 1 or 2 days after the spontaneous LH rise? A prospective RCT. Hum Reprod. 2014 Apr;29(4):697-703. doi: 10.1093/humrep/deu022. Epub 2014 Feb 18.

    PMID: 24549212RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Antonio Requena, PhD, MD

    IVI Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Requena, PhD, MD

CONTACT

911802900Antonio.Requena@ivi.es

Maria Cruz, PhD

CONTACT

911802900Maria.Cruz@ivi.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD MD

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 19, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

October 1, 2016

Last Updated

May 19, 2015

Record last verified: 2015-05