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Effectiveness of Intrauterine Growth Hormone Administration as an add-on Therapy to Conventional Hormone Therapy Compared to Placebo in Patients With Thin Endometrium Undergoing Frozen Thawed Embryo Transfer

NCT06379659 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-09-19

No results posted yet for this study

Summary

The purpose of this clinical trial is to see if intrauterine growth hormone infusions can help subjects reach a suitable endometrial thickness in patients who are resistant to routine hormonal therapy for embryo transfer in the In Vitro Fertilization (IVF) cycle.

The primary aim of this study is to assess the effectiveness of injecting Growth hormone directly into the uterus to enhance endometrial thickness. Additionally, we aim to compare the likelihood of pregnancy between patients receiving the Growth hormone infusion and those receiving a placebo.

Conditions

Interventions

DRUG

Growh hormone

In this group, patients will receive growth hormone solution containing 1.99 milligrams of the drug dissolved in 1.5 milliliters of 0.9% saline solution (normal saline), in addition to standard hormonal therapy, starting from cycle day 10. Treatment sessions will be conducted at two-day intervals. In case of non-response to treatment (failure to reach a minimum endometrial thickness of 7 millimeters in the subsequent assessment), the patient will receive a maximum of 4 doses, and if response to treatment is observed, growth hormone infusion will be discontinued. All infusions will be administered intrauterinely via an Intrauterine Insemination (IUI) catheter.

OTHER

Placebo

Similar to the intervention group, from cycle day 10, an equal volume of 0.9% saline solution (normal saline) will be administered in addition to standard hormonal therapy. Treatment sessions will be conducted at two-day intervals. In case of non-response to treatment (failure to reach a minimum endometrial thickness of 7 millimeters in the subsequent assessment), the patient will receive a maximum of 4 doses, and if response to treatment is observed, placebo infusion will be discontinued. All infusions will be administered intrauterinely via an Intrauterine Insemination (IUI) catheter.

Sponsors & Collaborators

  • Isfahan University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2024-07-29
Completion
2024-09-14

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06379659 on ClinicalTrials.gov