CClinicalTrials.gg
Status unknownNCT00708539Updated Jul 2, 2008

A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.

A Phase 4 interventional study of progesterone and Progesterone in IVF - Luteal Phase Support After Embryo Transfer, sponsored by Nordica Fertility Clinic. Status unknown at 17 sites in 2 countries. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2008-07-02.

Sponsored by Nordica Fertility Clinic · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
2,686
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

To compare the effect of Crinone 8% administered once daily versus other vaginal progesterone in terms of ongoing pregnancy rate 5 weeks after embryo transfer as well as patient convenience.

02

Conditions studied

  • IVF - Luteal Phase Support After Embryo Transfer
03

In context

Lead sponsor

This is the only study on the registry with Nordica Fertility Clinic as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 18-40 years
  • Regular menstrual cyclus 25-35 days
  • both ovaries present
  • No more than 2 previous IVF attempts
  • Have given written informed consent

Exclusion criteria

Exclusion Criteria:

  • More than 2 previous attempts
  • Known drug abuse
  • Known allergies to the study medication
  • No embryo transfer performed in the study cycle
  • Previous participating in the study
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
2,686 participants (estimated)

Study arms

  • Active comparator
    1

    Crinone vaginal gel 8% 90 mg once daily

    Drug: progesterone

  • Active comparator
    2

    Progesterone mic 400 mg three times daily

    Drug: Progesterone

Interventions

  • Drugprogesterone

    90 mg, vaginal, once daily

    Also known as: crinone 8%

  • DrugProgesterone

    200 mg, vaginal, three times daily used in Denmark, 400 mg, vaginal, three times daily used in Sweden

    Also known as: Progestan in Denmark, Progesterone mic in Sweden

06

What researchers measure

Primary outcomes

  1. Equivalence in ongoing pregnancy per embryo transfer between the two groups

    Time frame: week 5 after embryo tranfer

Secondary outcomes

  1. Convenience for the patient

    Time frame: the treatment period (from the day of embryo transfer and 19 days ahead)

07

Study locations

16 of 17 sites recruiting
  • Faurskov fertility clinic
    Aalborg, 9000, Denmark
    Terminated
  • Brædstrup Sygehus
    Brædstrup, 8740, Denmark
    • Finn Hald · Contact
    Recruiting
  • Dronninglund sygehus
    Dronninglund, 9330, Denmark
    • Michael Aasted · Contact
    Recruiting
  • Dansk Fertilitetsklinik
    Frederiksberg, 2000, Denmark
    • Hans Krogh · Contact
    Recruiting
  • Herlev Hospital
    Herlev, 2730, Denmark
    • Jan Blaabjerg · Contact
    Recruiting
  • Holbæk Sygehus
    Holbæk, 4300, Denmark
    • Helle E Bredkær · Contact
    Recruiting
  • Hvidovre Hospital
    Hvidovre, 2650, Denmark
    • Helle Meinertz · Contact
    Recruiting
  • Rigshospitalet
    København Ø, 2100, Denmark
    • Anders N Andersen · Contact
    Recruiting
  • Odense IVF
    Odense, 5000, Denmark
    • Sven Rex · Contact
    Recruiting
  • Odense OUH
    Odense, 5000, Denmark
    • Lars Westergaard · Contact
    Recruiting
  • Roskilde Sygehus
    Roskilde, 4000, Denmark
    • Anette Lindhard · Contact
    Recruiting
  • Skive sygehus
    Skive, 7800, Denmark
    • Peter Humaidan · Contact
    Recruiting
  • Reproduktionscentrum, Sahlgrenska
    Göteborg, Sweden
    Recruiting
  • Karolinska
    Huddinge, Sweden
    Recruiting
  • RMC
    Malmö, Sweden
    Recruiting
  • Reproduktionscentrum
    Stockholm, Sweden
    Recruiting
  • Norrlandsuniversitets sjukhus
    Umeå, Sweden
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00708539
Lead sponsor
Nordica Fertility Clinic
Collaborators
Merck Serono International SA
First posted
Jul 2, 2008
Start date
Apr 2006
Primary completion
Dec 2008 (estimated)
Completion
Dec 2008 (estimated)
Last update
Jul 2, 2008

Study contacts

Svend Lindenberg
Contact
svend@lindenberg.dk
004533257000
Svend Lindenberg
principal investigator · Nordica Fertilityclinic
Svend Lindenberg
principal investigator · Nordica Fertility Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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