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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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110908007513N18
Enrollment
54
Registered
2024-03-14
Start date
2024-04-02
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility. Female Infertility

Interventions

Intervention 1: Intervention group: 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 sal

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Have at least a history of cycle cancellation due to a thin endometrium less than 7 mm following standard hormonal treatment Age 18-45 years Availability of =1 embryo with good quality Normal baseline hormones value including : Testosterone, Progesterone, Prolactin, LH, FSH

Exclusion criteria

Exclusion criteria: Internal genital anomalies Active intrauterine infection ET=7 on the 10th day of 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

Design outcomes

Primary

MeasureTime frame
Endometrial thickness. Timepoint: Baseline (10th day of 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 cycle. Method of measurement: Transvaginal ultrasonography.

Secondary

MeasureTime frame
Clinical Pregnancy Rate(The number of fetuses that have a heartbeat and are not ectopic). Timepoint: 6-8 of gestational week. Method of measurement: Transvaginal Ultrasonography.;Early pregnancy complications including early miscarriage (miscarriage in less than 12th gestational week) and Ectopic pregnancy. Timepoint: During the first 12 weeks of pregnancy. Method of measurement: Clinical and radiological evolution during 12 weeks of pregnancy.;Implantation rate(The number of gestational sacs to the number of transferred embryos). Timepoint: 6-8 of gestational week. Method of measurement: Transvaginal ultrasonography.;IVF cancellation rate(The number of patients who do not reach enough endometrial thickness for transferring despite maximum treatment). Timepoint: 2 days following the last dose of placebo or growth hormone. Method of measurement: Transvaginal ultrasonography.;Response to treatment (The number of patients that reach at least 7 mm of endometrial thickness). Timepoint: 2 days following the last dose of placebo or growth hormone. Method of measurement: Transvaginal ultrasonography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNastaran Zamani Dehkordi

Esfahan University of Medical Sciences

nastaran14zd@gmail.com+98 991 314 4001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jul 17, 2026