Clinical trial • Not applicable • Other

Progesterone for Infertility|Female infertility

Not applicable trial of Progesterone for Infertility|Female infertility. Randomised. 690 participants.

Overview

Trial Therapeutic Area
Other
Trial Disease
Infertility|Female infertility
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
14-11-2025
First CTIS Authorization Date
09-03-2026

Trial design

Randomised Not applicable trial across 4 sites in Denmark.

Randomised
Yes
Target Sample Size
690

Eligibility

Recruits 690 Only adult women are eligible and participants must be able to provide written informed consent ("Ability to provide written informed consent"); no vulnerable population selected (isVulnerablePopulationSelected: false)..

Vulnerable Population
Only adult women are eligible and participants must be able to provide written informed consent ("Ability to provide written informed consent"); no vulnerable population selected (isVulnerablePopulationSelected: false).

Inclusion criteria

  • {"criterion_text":"- Age 18-37 years\n- Scheduled for intrauterine insemination with homologous or donor sperm\n- Undergoing mild ovarian stimulation with letrozole\n- Ability to provide written informed consent"}

Exclusion criteria

  • {"criterion_text":"- Age > 37 years\n- Anovulation due to hypogonadotropic hypogonadism\n- Known hypersensitivity to progesterone or to hard fat listed as an excipient in the Summary of Product Characteristics (SmPC) for Cyclogest.\n- Known or suspected progesterone-sensitive malignant tumours\n- Porphyria\n- Known missed abortion or ectopic pregnancy\n- Active arterial or venous thromboembolism, severe thrombophlebitis, or a history of these conditions\n- Severe hepatic dysfunction or liver disease\n- Inability to speak or understand Danish sufficiently to comprehend oral and written study information"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Clinical pregnancy rate","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Live birth rate","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Biochemical pregnancy rate","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Early pregnancy loss","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Fetal miscarriage","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Perinatal outcomes: preterm birth, birth weight, congenital malformation, perinatal mortality","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Obstetric outcomes: hypertensive disorders of pregnancy, gestational diabetes, postpartum hemorrhage and cesarean section","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Hormone levels measured on the day of insemination, mid-luteal phase and ovulation trigger (optional)","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
690
Recruitment Window Months
45
Consent Approach
Written informed consent required from participants ("Ability to provide written informed consent"). Participants must understand Danish (exclusion: "Inability to speak or understand Danish sufficiently to comprehend oral and written study information"). Subject information and consent documents listed (e.g. L1_ICF_Habile personer; L1_SIS adults; L2_Other subject information leaflet).

Geography

Total Number Of Sites
4
Total Number Of Participants
690

Denmark

Earliest CTIS Part Ii Submission Date
22-02-2026
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
15
Number Of Sites
4
Number Of Participants
690

Sites

Site Name
Rigshospitalet
Department Name
Department of Gynecology, Fertility and Obstetrics
Contact Person Name
Kristine Løssl
Site Name
Region Midtjylland
Department Name
The Fertility Clinic, Horsens Regional Hospital
Contact Person Name
Kirstine Kirkegaard
Contact Person Email
fertilitet@horsens.rm.dk
Site Name
Region Hovedstaden
Department Name
The Fertility Clinic, Herlev Hospital
Contact Person Name
Maria Birkvad Rasmussen
Site Name
Region Hovedstaden
Department Name
The Fertility Clinic, Hvidovre Hospital
Contact Person Name
Nina la Cour Freiesleben

Sponsor

Primary sponsor

Full Name
Region Midtjylland
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"1,12","organisation_type":"Educational Institution"}
  • {"country":"Denmark","full_name":"Region Hovedstaden","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Denmark","full_name":"Rigshospitalet","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Denmark","full_name":"Region Hovedstaden","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Denmark","full_name":"Region Midtjylland","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Cyclogest 400 mg vagitorier
Active Substance
Progesterone
Modality
Small molecule
Routes Of Administration
VAGINAL USE
Route
VAGINAL USE
Authorisation Status
Authorised
Starting Dose
400 mg
Maximum Dose
800 mg
Combination Treatment
Yes

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