Assisted reproduction and the early luteal phase The effect of ovulation induction on the endocrine profile

Assisted reproduction and the early luteal phase The effect of ovulation induction on the endocrine profile - Assisted reproduction and the early luteal phase the effect of ovulation induction on the endocrine

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003304-39-DK

Enrollment

179

Registered

2014-06-02

Start date

2014-07-16

Completion date

Unknown

Last updated

2020-09-07

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

Conditions

Infertility, particularly the luteal phase during IVF MedDRA version: 17.1 Level: LLT Classification code 10016398 Term: Female infertility System Organ Class: 100000004872

Interventions

Trade Name: Lentogest Product Name: Lentogest Pharmaceutical Form: Solution for injection INN or Proposed INN: 17-alpha-hydroxyprogesterone caproate Current Sponsor code: G03DA03 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All participation patientes have to give a spoken and written informed concent. 1) Women 18-40 years of age, 2)BMI over 18 kg/m 2 or under 35 kg/m 2 3) Planed IVF or ICSI with GNRH protocol 4) Normale value of af FSH, LH, estradiol, TSH and prolaktin. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 179 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: women under 18 or over 40 years old, BMI under 18 kg/m 2 or over 35 kg/m 2, Women in GnRH agonist protocol, Severe ilness of heart, lung or kidney, epilepsy, endocrine disorder, koagulation disorder, allergy towards 17- hydroxy progesteron, progesteron, benzylalkohol, ethyloleat, hydroxypropylbetadex or water. Patientes with HIV or hepatitis infection. Secondarily if transferation is canceled.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the endocrine hormone levels in the luteal phase during fertility treatment.;Secondary Objective: Not applicable;Primary end point(s): Hormones level of 17-a-hydroxy progesterone, Progesterone, Estradiol, HCG, Inhibin A and possibly PAPP A and PP14 ;Timepoint(s) of evaluation of this end point: Date of pregnancy test, approximately 2 weekes	—

Secondary

Measure	Time frame
Secondary end point(s): Positive pregnancy test, clinical pregnancy and featus with heartbeat.;Timepoint(s) of evaluation of this end point: 7 weeks	—

Countries

Denmark

Contacts

Public ContactFertilitycenter

Odense University Hospital

Peter.Humaidan@rsyd.dk004520342687

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 15, 2026