Vaginal Versus Combined Use of Progesterone in Fresh IVF/... | NCT05089383

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

NCT05089383

Sponsor

University of Athens

Status

Unknown status

Last Update Posted

Oct 22, 2021Actual

Enrollment

698Estimated

Phase

Not provided

Conditions

Luteal Phase

Interventions

Utrogestan

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 14, 2021Actual

Primary Completion Date

Feb 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Oct 10, 2021

First Submission Date that Met QC Criteria

Oct 10, 2021

First Posted Date

Oct 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2021

Last Update Posted Date

Oct 22, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nikos Vlahos, Professor of Obstetrics, Gynecology and Assisted Reproduction, University of AthensPrincipal Investigator

Lead Sponsor

University of AthensOTHER

Collaborators

Name	Class
Iaso Maternity Hospital, Athens, Greece	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

698Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
combined progesterone group		patients will receive vaginal plus subcutaneous or per os progesterone	Drug: Utrogestan
Vaginal progesterone group		patients will receive vaginal progesterone	Drug: Utrogestan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Utrogestan	Drug	PROSPECTIVE STUDY	Vaginal progesterone group combined progesterone group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Live birth rate	The percentage of viable embryo after 20 weeks of gestation	9 months]
Abortion rate	Loss of pregnancy up to 20 weeks of gestation	20 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Infertile couples with an indication for IVF/ICSI (both Units).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vasiliki Dourou	Contact	+306977706799		vdourou@gmail.com
Nikolaos Vlachos	Contact			nfvlahos@gmail.com

Overall Officials

Name	Affiliation	Role
Nikolaos Vlachos	National and Kapodistrian University of Athens	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National and Kapodistrian University of Athens	Recruiting	Athens	Attica	11528	Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26148507	Background	van der Linden M, Buckingham K, Farquhar C, Kremer JA, Metwally M. Luteal phase support for assisted reproduction cycles. Cochrane Database Syst Rev. 2015 Jul 7;2015(7):CD009154. doi: 10.1002/14651858.CD009154.pub3.
18406835	Background	Practice Committee of the American Society for Reproductive Medicine. Progesterone supplementation during the luteal phase and in early pregnancy in the treatment of infertility: an educational bulletin. Fertil Steril. 2008 Apr;89(4):789-92. doi: 10.1016/j.fertnstert.2008.02.012.