A randomized controlled trial of intrauterine growth hormone for thin endometrium.
Intrauterine Growth Hormone did not significantly improve endometrial thickness or clinical pregnancy rates in this trial, though there was a numerical trend toward increased biochemical pregnancies that warrants further investigation.
Where it sits
this study against the rest of the hgh (somatropin) corpusSummary and findings
This randomized controlled trial evaluated the efficacy of intrauterine Growth Hormone (GH) in patients with thin endometrium. Participants received either six international units of GH or placebo. The primary outcome was final endometrial thickness, with secondary outcomes including pregnancy rates.
Abstract
Thin endometrium impairs assisted reproduction outcomes. Given the uncertain efficacy and safety profile of intrauterine Growth Hormone (GH) as a therapeutic intervention, this exploratory trial was designed to evaluate its role in treating patients with this condition. An add-on, randomized, double-blind, placebo-controlled trial was conducted. Participants were randomly assigned to receive either six international units of GH or placebo. The pre‑specified primary outcome was final endometrial thickness (ET). Secondary outcomes included biochemical pregnancy, clinical pregnancy, early miscarriage, and treatment response rate. Fifty-two patients were included in the per-protocol analysis, which served as the primary analysis for this exploratory trial. The analysis revealed no significant between-group difference in the final ET. Secondary analyses indicated that treatment response rates and the intensity of therapy required were comparable between groups. A numerical increase in biochemical pregnancy was observed with GH administration (47.6% vs. 23.8%; RD = 0.23, NNT = 4.2, p = 0.10), though the trial was not powered for this outcome. This did not translate into a statistically significant difference in clinical pregnancy rates. No ectopic pregnancies were reported. The administration of intrauterine GH did not result in a statistically or clinically meaningful improvement in ET. However, the observed numerical trend toward higher pregnancy rates, while not statistically significant, cannot exclude a possible biological effect that may warrant investigation in larger-scale trials. All pregnancy-related findings are exploratory and hypothesis-generating.Trial registration: This trial was registered on www.clinicaltrial.gov (NCT06379659) and the World Health Organization trial registry of IRAN (IRCT20110908007513N18).
Background
This study addresses the impact of thin endometrium on assisted reproduction outcomes, which is a known concern in fertility treatments. Prior research has suggested that Growth Hormone may have a role in improving endometrial conditions, but its efficacy and safety remain uncertain. This exploratory trial aims to evaluate the potential benefits of intrauterine GH in enhancing endometrial thickness and pregnancy outcomes.
Methods
The study was a randomized, double-blind, placebo-controlled trial involving 52 patients with thin endometrium. Participants were assigned to receive either six international units of GH or a placebo. The primary outcome was final endometrial thickness, while secondary outcomes included biochemical pregnancy, clinical pregnancy, early miscarriage, and treatment response rate.
Results
The primary endpoint, final endometrial thickness, did not show a significant difference between the GH and placebo groups. The biochemical pregnancy rate was 47.6% in the GH group compared to 23.8% in the placebo group, with a risk difference of 0.23 and a number needed to treat of 4.2 (p=0.10). No significant differences were noted in clinical pregnancy rates.
Interpretation
These findings suggest that while there was a numerical increase in biochemical pregnancy rates with GH, the lack of statistical significance indicates that the effect may not be clinically meaningful. The study's small sample size and exploratory nature limit the conclusions that can be drawn, and further research is necessary to confirm any potential benefits of GH in this context.
Key findings
- Final endometrial thickness did not differ significantly between groups.
- Biochemical pregnancy rates were 47.6% for GH vs. 23.8% for placebo; RD=0.23, NNT=4.2, p=0.10.
- No significant difference in clinical pregnancy rates was observed.
- Fifty-two patients were included in the per-protocol analysis.
Limitations
- small n=52
- not powered for secondary outcomes
- exploratory findings only
- no significant difference in primary outcome