Идёт набор NCT05569577

An Open Labeled RCT on the Effect of Additional hCG Injection for LPS on Pregnancy Outcomes in IHH Patients

Без фазы С лечением Luteal Phase Deficiency Luteal Phase Support Idiopathic Hypogonadotropic Hypogonadism

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Additional hCG injection, estrogen and dydrogesterone.
Кому может быть актуально: Состояния в реестре: Luteal Phase Deficiency, Luteal Phase Support, Idiopathic Hypogonadotropic Hypogonadism. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

An Open-labeled Prospective Randomized Controlled Trial on the Effect of Different Regimens for Luteal Phase Support on Pregnancy Outcomes in Patients With Idiopathic Hypogonadotropic Hypogonadism

Обзор

Luteal phase deficiency (LPD) accounts for most failures of assistant artificial reproduction (ART) and early pregnancy loss for patients with idiopathic hypogonadotropic hypogonadism (IHH). Luteal phase support (LPS) is one of the indispensable interventions in ART treatments for IHH patients, which includes progestin, estrogen, human chorionic gonadotropin (hCG), and GnRH agonists (GnRHa). We aim to verify additional hCG injection 48 hours following routine hCG trigger and ovulation for LPS on the basis of supplementation of estrogen and dydrogesterone could improve clinical pregnancy rate, cumulative pregnancy rate, live birth rate and the prevalence of early pregnancy loss and ovarian hyperstimulation syndrome (OHSS) by an open labeled, prospective, and randomized clinical trial (RCT) in IHH patients in a single center.

Подробное описание

Idiopathic hypogonadotropic hypogonadism (IHH) is a congenital disease caused by a variety of gene variants leading to dysfunction in the secretion of hypothalamic gonadotropin-releasing hormones (GnRHs), with a prevalence of 1:125 000 in females. Girls with IHH often suffer from lack of puberty onset, amenorrhea and infertility, complicated with psychological problems such as depression and anxiety, due to delayed diagnosis and inappropriate treatment. Luteal phase deficiency (LPD) accounts for most failures of assistant artificial reproduction (ART) and early pregnancy loss for IHH patients. We have reported a severe LPD during the early trimester in a case with secondary HH following craniopharyngioma resection and speculated similar LPD happen in IHH patients complicated with low clinical pregnancy rate and live birth rate. Therefore, luteal phase support (LPS) is one of the indispensable interventions in ART treatments for IHH patients, which includes progestin, estrogen, human chorionic gonadotropin (hCG), and GnRH agonists (GnRHa). We aim to verify additional hCG injection 48 hours following routine hCG trigger and ovulation for LPS on the basis of supplementation of estrogen and dydrogesterone could improve clinical pregnancy rate, cumulative pregnancy rate, live birth rate and the prevalence of early pregnancy loss and ovarian hyperstimulation syndrome (OHSS) by an open labeled, prospective, and randomized clinical trial (RCT) in IHH patients in a single center of the Obstetrics and Gynecology Hospital Affiliated to Fudan University. The onset of patients' mental and psychological diseases such as depression and anxiety rely on their reproductive needs and pregnancy outcomes, which will also be investigated in the current study. Moreover, the effect of clinical interventions to improve pregnancy outcomes and emotional disorders would be discussed.

Вмешательства

Препарат Additional hCG injection
An additional hCG injection of 2000-5000IU would be given 48 hours following routine hCG trigger and ovulation for LPS on the basis of supplementation of estrogen and dydrogesterone.
Препарат estrogen and dydrogesterone
estrogen and dydrogesterone

Первичные конечные точки

Clinical pregnancy rate [Срок оценки: 7 weeks]
Cumulative pregnancy rate [Срок оценки: 12 weeks]
Live birth rate [Срок оценки: 42 weeks or beyond]

Вторичные конечные точки (2)

Number of IHH patients ending in early pregnancy loss [Срок оценки: 12 weeks]
Number of IHH patients with ovarian hyperstimulation syndrome [Срок оценки: 12 weeks or beyond]

Критерии участия

Критерии включения

Clinical diagnosis of IHH (primary amenorrhea (with or without a history of hormone supplementation therapy); basic LH levels <5IU/L, FSH<5IU/L or normal; no organic lesions in the hypothalamus and pituitary MRI).
Women of childbearing age who desire to get pregnant