Investigating the effect of injecting the combination of exosomes extracted from follicular fluid, stem cells extracted from Wharton's jelly, platelets enriched from blood plasma and gonadotropins into the ovaries of poi, pof patients.

开始日期2024-02-20

申办/合作机构-

NCT06486870 / Completed临床3期IIT

Comparative Study Between Two Ovulation Induction Therapies and Laparoscopic Ovarian Drilling on Clinical Outcomes in Clomiphene Citrate-Resistant PCOS Women

Polycystic ovary syndrome (PCOS) is a prevalent endocrine disorder affecting 4-8% of reproductive-aged women and is a leading cause of infertility due to oligo-anovulation (1). Studies suggest a higher prevalence of 17.8-19.9% based on Rotterdam diagnostic criteria. PCOS is diagnosed by the presence of at least two out of three criteria: oligo- and/or anovulation, hyperandrogenism, and polycystic ovaries, with other etiologies excluded (2). Clomiphene citrate (CC), a selective estrogen receptor modulator, has been the first-line treatment for inducing ovulation in anovulatory women with PCOS for decades. Approximately 80% of women resume ovulation with CC, but only 35-40% achieve pregnancy. About 15-40% of women are resistant to CC, defined as failure to ovulate after receiving a maximum dosage of 150 mg per day for 5 days starting on the third day of the menstrual cycle. For CC-resistant women, metformin, an insulin sensitizer, has been explored but shows limited effectiveness except in combination with CC. Gonadotropins are the standard treatment for CC-resistant PCOS but come with risks of multiple pregnancies and ovarian hyperstimulation syndrome (OHSS) (3). Letrozole, an aromatase inhibitor, is another treatment option that prevents the conversion of androgens to estrogen, thereby increasing gonadotropin-releasing hormone (GnRH) secretion and promoting ovulation. Letrozole has shown superior ovulation and live birth rates compared to CC and is now recommended as the first-line treatment for anovulation in women with PCOS. It has comparable rates of OHSS and miscarriage to CC, but fewer relevant studies have compared it directly to laparoscopic ovarian drilling (LOD) (4). LOD is an alternative to gonadotropins for inducing ovulation in CC-resistant PCOS. It involves surgical intervention, which can be either unilateral or bilateral, and is effective without the risks of multiple pregnancies or OHSS. LOD also increases ovarian responsiveness to CC. Despite minimal morbidity, LOD can lead to tubo-ovarian adhesions and premature ovarian failure, although these risks are reduced by careful technique (5).

开始日期2020-01-01

申办/合作机构

Cairo University

NCT00894608 / Unknown statusN/A

Letrozole Combined With Gn for Ovarian Hyperstimulation Undergoing IVF/ICSI in Patients With PCOS

The purpose of this study is to determine whether letrozole combined with gonadotropins are effective in the ovarian hyperstimulating for IVF/ICSI in patients with PCOS.

开始日期2008-01-01

申办/合作机构-

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2024-01-05·Human reproduction (Oxford, England)

The burden of very early dropout in infertility care: a nationwide population-based cohort study

Article

作者: Guibert, Juliette ; Bouyer, Jean ; de La Rochebrochard, Elise ; Ben Messaoud, Khaoula

Abstract:

STUDY QUESTION:

What is the frequency and the associated factors of very early dropout following unsuccessful clomiphene citrate (CC)/gonadotropin treatment in the context of full coverage of treatment cost.

SUMMARY ANSWER:

Despite free treatment, almost one in four women had a very early dropout following unsuccessful CC/gonadotropin treatment, with patients below the poverty line being more likely to drop out early.

WHAT IS KNOWN ALREADY:

Success of infertility care is tarnished by very high dropout rates. Infertility care dropout has been considered as resulting principally from financial barriers because of the high cost of treatment. Nearly all previous work addressed dropout following IVF/ICSI. Factors associated with dropout following CC/gonadotropins may be different and also need to be investigated.

STUDY DESIGN, SIZE, DURATION:

Nationwide population-based cohort study.

PARTICIPANTS/MATERIALS, SETTING, METHODS:

Using the French national health insurance and hospital databases, we included in the cohort 27 416 women aged 18–49 years unsuccessfully treated with CC/gonadotropins in 2017. The main outcome was very early dropout, defined as discontinuation of all infertility treatment after unsuccessful treatment for 1–3 months. Very early treatment dropout was analysed by multivariate logistic regression.

MAIN RESULTS AND THE ROLE OF CHANCE:

Among women unsuccessfully treated with CC/gonadotropins, 22% dropped out of infertility care within 3 months. In multivariate analysis, higher early dropout following unsuccessful CC/gonadotropin treatment was associated with older and younger ages (≥35 and <25 years), being below the poverty line, being treated with CC prescribed by a general practitioner and lack of infertility tests or monitoring.

LIMITATIONS, REASONS FOR CAUTION:

This study is based on health administrative data that do not include reasons for dropout and record only a limited amount of information. It is thus not possible to analyse the reason for early dropout.

WIDER IMPLICATIONS OF THE FINDINGS:

Despite full coverage of all infertility treatment, women under the poverty line have a higher risk of very early dropout following unsuccessful CC/gonadotropin treatment. Better understanding is needed of the non-financial barriers and difficulties faced by these patients. To address disparities in infertility treatment, practitioner training could be reinforced to adapt to patients from different social and cultural backgrounds.

STUDY FUNDING/COMPETING INTEREST(S):

This work was supported by the ANR StimHo project, grant ANR-17-CE36-0011-01 from the French Agence Nationale de la Recherche. The authors have no conflict of interest to declare.

TRIAL REGISTRATION NUMBER:

N/A.

2024-01-03·European journal of endocrinology

Gonadotropins for pubertal induction in males with hypogonadotropic hypogonadism: systematic review and meta-analysis

Review

作者: Varughese, Rachel ; Unadkat, Ayesha ; Howard, Sasha R ; Faruqi, Duaa ; Hoskyns, Rebecca ; Ng Yin, Kyla ; Farquhar, Robert ; Alexander, Emma C

Abstract:

Objective:

Hypogonadotropic hypogonadism is characterized by inadequate secretion of pituitary gonadotropins, leading to absent, partial, or arrested puberty. In males, classical treatment with testosterone promotes virilization but not testicular growth or spermatogenesis. To quantify treatment practices and efficacy, we systematically reviewed all studies investigating gonadotropins for the achievement of pubertal outcomes in males with hypogonadotropic hypogonadism.

Design:

Systematic review and meta-analysis.

Methods:

A systematic review of Medline, Embase, Global Health, and PsycINFO databases in December 2022. Risk of Bias 2.0/Risk Of Bias In Non-randomized Studies of Interventions/National Heart, Lung, and Blood Institute tools for quality appraisal. Protocol registered on PROSPERO (CRD42022381713).

Results:

After screening 3925 abstracts, 103 studies were identified including 5328 patients from 21 countries. The average age of participants was <25 years in 45.6% (n = 47) of studies. Studies utilized human chorionic gonadotropin (hCG) (n = 93, 90.3% of studies), human menopausal gonadotropin (n = 42, 40.8%), follicle-stimulating hormone (FSH) (n = 37, 35.9%), and gonadotropin-releasing hormone (28.2% n = 29). The median reported duration of treatment/follow-up was 18 months (interquartile range 10.5-24 months). Gonadotropins induced significant increases in testicular volume, penile size, and testosterone in over 98% of analyses. Spermatogenesis rates were higher with hCG + FSH (86%, 95% confidence interval [CI] 82%-91%) as compared with hCG alone (40%, 95% CI 25%-56%). However, study heterogeneity and treatment variability were high.

Conclusions:

This systematic review provides convincing evidence of the efficacy of gonadotropins for pubertal induction. However, there remains substantial heterogeneity in treatment choice, dose, duration, and outcomes assessed. Formal guidelines and randomized studies are needed.

2024-01-01·Stem cell reviews and reports

Synergistic Effect of Human Chorionic Gonadotropin and Granulocyte Colony Stimulating Factor in the Mobilization of HSPCs Improves Overall Survival After PBSCT in a Preclinical Murine Model. Are We Far Enough for Therapy?

Article

作者: Gherman, Luciana Madalina ; Cismaru, Cosmin Andrei ; Chira, Sergiu ; Gulei, Diana ; Isachekcu, Ekaterina ; Cismaru, Gabriel ; Tomuleasa, Ciprian ; Berindan Neagoe, Ioana ; Munteanu, Raluca ; Jurj, Ancuta

Strategies to improve hematopoietic stem and progenitor cell (HSPC) mobilization from the bone marrow can have a pivotal role in addressing iatrogenic bone-marrow insufficiency from chemo(radio)therapy and overcoming peripheral blood stem cell transplantation (PBSCT) limitations such as insufficient mobilization. Granulocyte-colony stimulating factor (G-CSF) represents the standard mobilization strategy for HSPC and has done so for more than three decades since its FDA approval. Its association with non-G-CSF agents is often employed for difficult HSPC mobilization. However, obtaining a synergistic effect between the two classes is limited by different timing and mechanisms of action. Based on our previous in vitro results, we tested the mobilization potential of human chorionic gonadotropin (HCG), alone and in combination with G-CSF in vivo in a murine study. Our results show an improved mobilization capability of the combination, which seems to act synergistically in stimulating hematopoiesis. With the current understanding of the dynamics of HSPCs and their origins in more primitive cells related to the germline, new strategies to employ the mobilization of hematopoietic progenitors using chorionic gonadotropins could soon become clinical practice.

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ESPE2023	N/A	性腺机能减退 luteinising hormone (LH) \| follicle-stimulating hormone (FSH)	-	hCG	製鬱築醖構鏇構餘鬱醖(廠壓願遞鑰簾醖構襯廠) = 鑰齋鬱艱網顧醖淵齋淵構選鏇鬱觸觸顧餘齋艱 (簾製壓願艱襯積積製構, 25.0 ~ 56.1)	-	2023-09-21
				hCG + FSH	製鬱築醖構鏇構餘鬱醖(廠壓願遞鑰簾醖構襯廠) = 餘製獵鑰衊醖範齋夢餘構選鏇鬱觸觸顧餘齋艱 (簾製壓願艱襯積積製構, 80.2% ~ 88.4%)
ASCO2008	N/A	癌症	28	exogenous gonadotropins (Cancer patients)	鏇壓鏇鹹壓蓋衊繭鬱艱(獵繭醖淵獵壓膚餘選鑰) = 鏇積積獵願醖觸鏇選構鑰鏇獵蓋餘鏇願夢憲範 (繭觸淵餘積遞醖網鬱憲, +/ ~ 712)	-	2008-05-20
				exogenous gonadotropins (Controls)	鏇壓鏇鹹壓蓋衊繭鬱艱(獵繭醖淵獵壓膚餘選鑰) = 鏇鹹簾構選鑰廠簾鏇選鑰鏇獵蓋餘鏇願夢憲範 (繭觸淵餘積遞醖網鬱憲, +/ ~ 021)