Infertility Clinical Trial
Official title:
Effectiveness of Intrauterine Growth Hormone Infusion as an add-on Therapy to Conventional Hormone Therapy Compared to Placebo in Patients With Thin Endometrium Undergoing Frozen Thawed Embryo Transfer: A Double-blinded Parallel Exploratory Randomized Controlled Clinical Trial
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.
Status | Recruiting |
Enrollment | 54 |
Est. completion date | November 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Isfahan Shahid Beheshti hospital, Hazrat e Maryam Fertility Center | Isfahan |
Lead Sponsor | Collaborator |
---|---|
Isfahan University of Medical Sciences |
Iran, Islamic Republic of,
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. — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
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 — View Citation
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Clinical Pregnancy Rate | The number of fetuses that have a heartbeat and are not ectopic evaluated by Transvaginal Ultrasonography | 6-8 of gestational week | |
Secondary | Response to treatment | The number of patients that reach at least 7 mm of endometrial thickness | 2 days following the last dose of placebo or growth hormone | |
Secondary | Implantation rate | The number of gestational sacs to the number of transferred embryos evaluated by Transvaginal ultrasonography | 6-8 of gestational week | |
Secondary | IVF cancellation rate | The number of patients who do not reach enough endometrial thickness for transferring despite maximum treatment | 2 days following the last dose of placebo or growth hormone | |
Secondary | Early pregnancy complications | Including early miscarriage (miscarriage in less than 12th gestational week) and Ectopic pregnancy | During the first 12 weeks of pregnancy |
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