The Role of hCG in Thawed Embryo Transfer | NCT07004192

Studies
The Role of hCG in Thawed Embryo Transfer

NCT07004192

Sponsor

Fertility Center of Las Vegas

Status

Recruiting

Last Update Posted

Jul 1, 2025Actual

Enrollment

220Estimated

Phase

Phase 4

Conditions

Infertility (IVF Patients)

Interventions

HCG injection
No intervention

Countries

United States

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

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2, 2025Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

May 27, 2025

First Submission Date that Met QC Criteria

May 27, 2025

First Posted Date

Jun 4, 2025Actual

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

Jun 26, 2025

Last Update Posted Date

Jul 1, 2025Actual

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

This prospective randomized trial will assess the relevance, if any, of a corpus luteum induced by hCG in transfers of thawed embryos.

Detailed Description

The current study is designed to carefully isolate the effect of a corpus luteum by ensuring that the presence or absence of a corpus luteum is the only difference between two study arms. This should be reliably achieved by administering an injection of hCG in one study arm, while the other study arm has identical treatment except for omitting the hCG.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hCG Group	Experimental	This group receives one injection of hCG.	Drug: HCG injection
No hCG Group	Active Comparator	This arm receives no hCG.	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HCG injection	Drug	5000 IU hCG injection	hCG Group
No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure	Mean arterial pressure measured in third trimester of pregnancy	Third trimester of pregnancy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female adult expecting to receive transfer of a thawed embryo.
At least one available frozen blastocyst of transferrable quality.
Non-menopausal female with at least one antral follicle.
Use of pre-implantation genetic testing (PGT), embryos derived from donor oocytes and/or donor sperm, a gestational carrier, and history of prior transfer(s) regardless of outcome are allowed.
Subsequent embryo transfers after failed transfers under this study are allowed, but not after a transfer that has resulted in ongoing pregnancy at ten weeks gestation under this study.

Exclusion Criteria:

Minors (age<18 years).
Use of embryo(s) frozen at another center.
Patient insistent on transfer of two embryos.
Patient or partner unable to provide informed consent in English.
Patient already enrolled in any other research study for her embryo transfer.
History of anti-phospholipid syndrome or any other indication for use of Lovenox in pregnancy.
Patient for whom the physician assesses this protocol is inappropriate or unsafe.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shironda Research Assistant	Contact	702-254-1777	265	shironda@fertilitycenterlv.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fertility Center of Las Vegas	Recruiting	Las Vegas	Nevada	89113	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

No current plan to do so in approved protocol.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases