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

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

This study was designed as a randomized controlled exploratory clinical trial on 54 patients, controlled with a parallel placebo group and random allocation using an online based system.

This study will be conducted at Hazrat-e Maryam fertility Center, Isfahan on patients with thin endometrium resistant to routine treatment. In this study, patients will receive intrauterine infusion of growth hormone or placebo in addition to routine hormonal treatment. Patients and the outcome assessor will be blinded to the study groups.

18-45 years individuals with at least one canceled embryo transfer cycle due to endometrial thickness less than 7 millimeters following receiving standard hormonal therapy, and have normal hormones level (testosterone, progesterone, prolactin, LH, and FSH), with at least one suitable embryo are enrolled following obtaining consent. Individuals with endometrial thickness of 7 millimeters or more on cycle day 10, and those with a history of uterine abnormalities will be excluded from the study.

The drug group receives intrauterine growth hormone therapy in addition to routine Estrogen treatment, and placebo group receives intrauterine placebo therapy in addition to routine Estrogen treatment. The group receiving growth hormone therapy receives 1.99 milligrams of the drug dissolved in 1.5 milliliters of 0.9% Saline solution per treatment session through intrauterine infusion, while the placebo group receives an equal volume of normal Saline as a placebo.

Endometrial thickness measured using transvaginal ultrasonography on the day of embryo transfer.

The random allocation process will be conducted utilizing the random number generation feature provided by the https://www.sealedenvelope.com/ website, employing Variable Size block randomization with a 1:1 allocation ratio across blocks of 4, 6, and 8. The random numbers generated will be segregated into two equal groups denoted as Group A (representing Growth Hormone) and Group B (representing Placebo), each assigned a specific code generated by the aforementioned website. Subsequently, each enrolled patient will be allocated to either the Placebo or Growth Hormone group based on the generated random list. Throughout the study, one researcher, tasked with patient allocation, will prepare the drug or placebo, while another researcher, blinded to the study group, will administer the injection.

In this study, patients will not be aware of their administered medication. Additionally, the random allocation of patients to groups will be conducted by another researcher, and the administering physician will be unaware of the allocation of patients to each group. For blinding, the evaluating physician and the prescribing physician in patients not receiving growth hormone will be injected with an identical placebo on similar days. 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. Additionally, the outcome assessor (clinical pregnancy rate, ET) will be completely blinded to the treatment groups. Laboratory personnel will also be completely unaware of the study groups.