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 | Completed Phase 1

• 2 other identifiers: IR.MUI.MED.REC.1402.449IRCT20110908007513N18
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Thin Endometrium; Infertility Female; Infertility

Keywords

Infertility; Infertility, Female; endometrial thickness; Thin Endoetrium; Growth Hormone; Human Growth Hormone; Somatropin; Intra-uterine infusion

Outcome Measures

Primary Outcomes (1)

• Endometrial thickness

  Measurement of endometrial thickness will be performed utilizing transvaginal sonography due to its closer proximity to the endometrium and with an empty bladder. To minimize the potential bias of measuring endometrial thickness during uterus contraction, occur during contractions, measurements will be taken only after the patient's contractions have ceased.

  Baseline (On the 10th day of menstrual cycle), and On the day of response to treatment (in case of response) and in case of non-response to treatment on the 18th day of the mesntrual cycle

Secondary Outcomes (5)

• Clinical Pregnancy Rate

  6-8 of gestational week

• Response to treatment

  2 days following the last dose of placebo or growth hormone

• Implantation rate

  6-8 of gestational week

• IVF cancellation rate

  2 days following the last dose of placebo or growth hormone

• Early pregnancy complications

  During the first 12 weeks of pregnancy

Study Arms (2)

Growth hormone

ACTIVE COMPARATOR

Drug: Growh hormone

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Growh hormone DRUG

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.

Growth hormone

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• At least a history of cycle cancellation due to a thin endometrium less than 7 mm following standard hormonal treatment
• Availability of ≥1 embryo with good quality
• Normal baseline hormones value including: Testosterone, Progesterone, Prolactin, Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH)

You may not qualify if:

• Internal genital anomalies
• Active intrauterine infection Endometrial thickness≥7 on the 10th day of menstrual cycle
• History of Asherman syndrome
• History of cancer
• History of uterine surgery in past 3 months
• Intrauterine polyps visible in Transvaginal Ultrasonography
• Visible intrauterine adhesion
• Pathospermia in partner
• Premature ovarian failure

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Isfahan Shahid Beheshti hospital, Hazrat e Maryam Fertility Center

Isfahan, 8174673461, Iran

Location

Related Publications (6)

• Yu H, Gao S, Tang H, Chen H, Deng Z, Yang L, et al. Growth hormone intrauterine perfusion combined with replacement cycle in the treatment of non-response thin endometrium: report of 5 cases. Int J Clin Exp Med. 2016;9(6):11982-9

  RESULT

• Hosseini Aghdam S, Ghasemzadeh A, Farzadi L, Hamdi K, Baradaran-Binazir M, Nouri M, Fattahi A, Dttrich R. Growth Hormone: A Potential Treatment of Patients with Refractory Thin Endometrium: A Clinical Trial Study. Int J Fertil Steril. 2022 Oct 9;16(4):251-255. doi: 10.22074/ijfs.2022.541389.1210.

  PMID: 36273309 RESULT

• Li W, Cao Z, Yu X, Hu W. Effect of growth hormone on thin endometrium via intrauterine infusion. Ann Transl Med. 2021 Aug;9(16):1325. doi: 10.21037/atm-21-3583.

  PMID: 34532462 RESULT

• Altmae S, Aghajanova L. Growth Hormone and Endometrial Receptivity. Front Endocrinol (Lausanne). 2019 Sep 24;10:653. doi: 10.3389/fendo.2019.00653. eCollection 2019.

  PMID: 31616379 RESULT

• Liu KE, Hartman M, Hartman A. Management of thin endometrium in assisted reproduction: a clinical practice guideline from the Canadian Fertility and Andrology Society. Reprod Biomed Online. 2019 Jul;39(1):49-62. doi: 10.1016/j.rbmo.2019.02.013. Epub 2019 Mar 20.

  PMID: 31029557 RESULT

• Fu LL, Xu Y, Yan J, Zhang XY, Li DD, Zheng LW. Efficacy of granulocyte colony-stimulating factor for infertility undergoing IVF: a systematic review and meta-analysis. Reprod Biol Endocrinol. 2023 Apr 3;21(1):34. doi: 10.1186/s12958-023-01063-z.

  PMID: 37013570 RESULT

MeSH Terms

Conditions

Infertility, Female; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: In this study, a double-blind methodology will be employed to minimize bias. Patients will be administered medication without knowing the study group and placebo or treatment intervention. To ensure uniformity between growth hormone and placebo, which has a similar appearance to the placebo, will be prepared by an individual informed of the enrolled patients in the study and will be provided to the administering physician. The evaluator assessing outcomes such as clinical pregnancy rate and endometrial thickness will not know which treatment each patient received. Laboratory staff will also be unaware of the treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Associated professor of Infertility and In-Vivo-Fertilization

Model Details: This study was designed as a randomized controlled exploratory clinical trial, controlled with a parallel placebo group and random allocation using an online based system.

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 23, 2024
• Study Start: May 1, 2024
• Primary Completion: July 29, 2024
• Study Completion: September 14, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)