Rectally administered micronized progesterone for luteal phase support in hormone replacement therapy frozen embryo transfer (HRT-FET) cycle – non-inferiority randomized controlled trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Midtjylland

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Decision date (initial)

2023-06-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The aim of this study is to investigate the ongoing pregnancy rate (OPR) week 12 in HRT-FET cycles after rectally administered progesterone as the only administered progesterone and is there a non-inferior different to vaginal LPS in HRT-FET cycles. Furthermore, what is the optimal serum P4 level after rectally micronized progesterone administration in HRT-FET.

Secondary objectives 1

1. Secondary end-points are positive hCG rate, clinical pregnancy, pregnancy loss, LBR, mean P4 levels in Group B (study group) and the relation to OPR. Urine progesterone levels in the two groups and the relation to OPR. Side effects and patient convenience regarding rectally administration of Cyclogest. Complications during the pregnancy e.g. hypertension and preeclampsia.

Conditions and MedDRA coding

Infertility

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 18-46 years
2. BMI >18.5 <34 kg/m²
3. Day 5 vitrified blastocyst available for transfer after thawing
4. Speaking and understanding Danish

Exclusion criteria 10

1. Has a contraindication or history to Cyclogest or components there of; or has a history of drug or allergy that, in the opinion of the investigator contraindicates study participation.
2. Inflammatory bowel disease (Colitis ulcerosa and Mb. Crohn),
3. Endometrium <7 mm after 12-20 days of 6 mg estradiol treatment.
4. Previous enrolment in the trial.
5. No blastocyst for transfer.
6. Uterine abnormalities
7. Oocyte donation.
8. Dysregulated severe chronical medical diseases.
9. Patients who are treated with medication metabolized by CYP3A4 enzymes.
10. Violation of the protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Ongoing pregnancy rate week 12 after HRT-FET with rectally administered progesterone, only.

Secondary endpoints 8

1. Positive hCG rate,
2. Clinical pregnancy,
3. Pregnancy loss,
4. LBR,
5. Mean P4 levels in Group B (study group) and the relation to OPR.
6. Urine progesterone levels in the two groups and the relation to OPR.
7. Side effects and patient convenience regarding rectally administration of Cyclogest.
8. Complications during the pregnancy e.g. hypertension and preeclampsia.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Midtjylland

Sponsor organisation

Region Midtjylland

Address

Resenvej 25

City

Skive

Postcode

7800

Country

Denmark

Scientific contact point

Organisation

Fertiltetsklinikken, Regionshospitalet Skive

Contact name

Peter Humaidan

Public contact point

Organisation

Fertiltetsklinikken, Regionshospitalet Skive

Contact name

Peter Humaidan

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications