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Vaginal Versus Combined Use of Progesterone in Fresh IVF/ICSI Cycles

Vaginal Versus Combined Use of Progesterone in Fresh IVF/ICSI Cycles

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05089383
Enrollment
698
Registered
2021-10-22
Start date
2021-09-14
Completion date
2023-12-31
Last updated
2021-10-22

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

Conditions

Luteal Phase

Keywords

IVF, PROGESTERONE

Brief summary

Hypothesis: the combined use of progesterone administration for luteal phase support is superior to the single route of progesterone administration in terms of pregnancy outcome parameters in women undergoing fresh IVF/ICSI cycles.

Detailed description

In ART (IVF/ICSI), most of the studies have shown a deficiency of progesterone during the luteal phase, especially due to the use of GnRH analogs. The lack of progesterone leads to abnormal endometrial development and consequently to desynchronization between the latter and the blastocyst implantation. Therefore, it is a standard of care to use progesterone for luteal phase support after embryo transfer and during the first trimester, in case of pregnancy. According to ESHRE guidelines, either of vaginal, oral, subcutaneous or intramuscular route is advisable. But, until now, there is no robust evidence on the effect on pregnancy outcome of the combined route of progesterone administration compared to the standard of care (single route). The aim of this study is to compare the effectiveness of the combined route of progesterone administration to the single route. The study is a prospective cohort study. Participants will receive either standard treatment with single route (vaginal) progesterone administration according to the ESHRE guidelines, or combination of more than one routes of administration, that is vaginal plus oral or subcutaneous progesterone, starting afterthe fresh embryo transfer until 12 weeks of gestation or a negative pregnancy test.

Interventions

PROSPECTIVE STUDY

Sponsors

Iaso Maternity Hospital, Athens, Greece
CollaboratorOTHER
University of Athens
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
22 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with a documented history of infertility, aged 22-40, undergoing fresh embryo transfer after IVF/ICSI, under informed consent. * Physiological menstrual cycles (24-35 days), normal endocrine function (FSH ≤ 15 IU / ml), transvaginal ultrasound without pathological findings, free personal medical history, indication for IVF/ICSI.

Exclusion criteria

* Endocrine or metabolic disorders, e.g., PCO (S), pathology of the uterus and/or endometrium, basal FSH levels\> 15 IU / ml, major surgery in the ovaries (removal), and age \<22 years and \> 40 years old. * Active pelvic inflammatory disease * IVF/ICSI with donor eggs * Previous participation in this trial

Design outcomes

Primary

MeasureTime frameDescription
Live birth rate9 months]The percentage of viable embryo after 20 weeks of gestation
Abortion rate20 weeksLoss of pregnancy up to 20 weeks of gestation

Countries

Greece

Contacts

Primary ContactVasiliki Dourou
vdourou@gmail.com+306977706799
Backup ContactNikolaos Vlachos
nfvlahos@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026