The effect of adding extra rectally progesterone when the serum progesterone level is too low during infertility treatment with thawed embryos.

Optimizing serum progesterone level during luteal phase in hormone replacement therapy frozen embryo transfer (HRT-FET) cycle – interventional and observational trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001539-29-DK

Enrollment

224

Registered

2019-08-21

Start date

2019-10-11

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

Infertility MedDRA version: 21.0 Level: PT Classification code 10021926 Term: Infertility System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: Cyclogest Product Name: Cyclogest Pharmaceutical Form: Vaginal capsule INN or Proposed INN: PROGESTERONE CAS Number: 57-83-0 Concentration unit: mg milligram(s) Concentration type: equal C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 18-45 years • BMI >18.5 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Endometrium <7 mm after 12-20 days of 6 mg estradiol treatment. • Previous enrolment in the trial • No blastocyst for transfer • Uterine abnormalities • Oocyte donation • Dysregulated severe chronical medical diseases • Violation of the protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to investigate the effect of adding progesterone rectally in hormone replacement treatment frozen embryo transfer (HRT-FET) cycles if the serum progesterone (P4) is <35nmol/l on embryo transfer day. ;Secondary Objective: Secondary end-points are positive hCG rate, clinical pregnancy, early pregnancy loss, live birth, mean P4 levels in the groups =35nmol/l and <35nmol/l and in the latter group before and after adding rectally progesterone, live birth, side effect to rectally administration of Cyclogest, urine progesterone level, saliva free progesterone level, the vaginal microbiota in relation to serum progesterone level. Side effects and patient convenience regarding rectally administration of Cyclogest.;Primary end point(s): Ongoing pregnancy rate gestational week 12+0.;Timepoint(s) of evaluation of this end point: Gestational week 12+	—

Measure

Time frame

Main Objective: The aim of this study is to investigate the effect of adding progesterone rectally in hormone replacement treatment frozen embryo transfer (HRT-FET) cycles if the serum progesterone (P4) is <35nmol/l on embryo transfer day. ;Secondary Objective: Secondary end-points are positive hCG rate, clinical pregnancy, early pregnancy loss, live birth, mean P4 levels in the groups =35nmol/l and <35nmol/l and in the latter group before and after adding rectally progesterone, live birth, side effect to rectally administration of Cyclogest, urine progesterone level, saliva free progesterone level, the vaginal microbiota in relation to serum progesterone level. Side effects and patient convenience regarding rectally administration of Cyclogest.;Primary end point(s): Ongoing pregnancy rate gestational week 12+0.;Timepoint(s) of evaluation of this end point: Gestational week 12+

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary end-points are positive hCG rate, clinical pregnancy, early pregnancy loss, live birth, mean P4 levels in the groups =35nmol/l and <35nmol/l and in the latter group before and after adding rectally progesterone, live birth, side effect to rectally administration of Cyclogest, urine progesterone level, saliva free progesterone level, the vaginal microbiota in relation to serum progesterone level. Side effects and patient convenience regarding rectally administration of Cyclogest.;Timepoint(s) of evaluation of this end point: At birth.	—

Measure

Time frame

Secondary end point(s): Secondary end-points are positive hCG rate, clinical pregnancy, early pregnancy loss, live birth, mean P4 levels in the groups =35nmol/l and <35nmol/l and in the latter group before and after adding rectally progesterone, live birth, side effect to rectally administration of Cyclogest, urine progesterone level, saliva free progesterone level, the vaginal microbiota in relation to serum progesterone level. Side effects and patient convenience regarding rectally administration of Cyclogest.;Timepoint(s) of evaluation of this end point: At birth.

—

Countries

Denmark

Contacts

Public ContactThe Fertility Clinic, Skive Regiona

The Fertility Clinic, Skive Regional Hospital

birgit.alsbjerg@midt.rm.dk+4578445760

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026