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Infertility, Female clinical trials

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NCT ID: NCT06292806 Not yet recruiting - Infertility, Female Clinical Trials

Inhibin B/AFC Ratio for Ovarian Response

Start date: March 1, 2024
Phase:
Study type: Observational [Patient Registry]

Ovarian response to gonadotropin stimulation plays a major role in the success of in vitro fertilization (IVF). Anti-müllerian hormone (AMH), inhibin B, and antral follicle count (AFC) are ovarian reserve markers and also predictors of the ovarian response, as they correlate with the number of oocytes retrieved. Ovarian responsiveness can also be assessed through the Follicular Output Rate (FORT), which evaluates the proportion of follicles that developed during stimulation by the ratio of PFC (preovulatory follicle count) to AFC. FORT highlights that some follicles do not respond to the FSH; therefore, this project proposes an endocrinological approach to this issue by relating AFC to inhibin B and AMH ㅡ hormones produced by granulosa cells, but at different stages of folliculogenesis and with endocrine and paracrine functions, respectively. The inhibin B/AFC and AMH/AFC ratios correlated with FORT and the number of oocytes retrieved may help elucidate the mechanisms involved in follicular responsiveness. A prospective cohort study will be conducted with patients of the Insemine Center for Human Reproduction. Antral follicle count and AMH measurement will be performed before IVF cycle initiation, and inhibin B measurement will be carried out on a blood sample collected on the fifth day of ovarian stimulation. The primary outcomes will be the Follicular Output Rate (FORT) and the number of oocytes retrieved. Secondary outcomes include the number of metaphase II oocytes, oocyte quality, fertilization rate and embryo quality.

NCT ID: NCT06263192 Completed - Infertility, Female Clinical Trials

Pregnancy Prediction Using Anti-Müllerian Hormone in Intrauterine Insemination Cycles

Start date: October 1, 2020
Phase:
Study type: Observational

The goal of this study is to compare the cumulative pregnancy rates after 4 artificial inseminations with donor (IAD) in non-sterile women with plasma AMH levels > and < 1.1 ng/mL.

NCT ID: NCT06261658 Recruiting - Infertility, Female Clinical Trials

Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma

TESOVA2022
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The study is aimed to evaluate the effects of intraovarian injection of autologous Platelet-enriched Autologous Plasma on the outcomes of orthotopic transplantation of cryopreserved ovarian tissue.

NCT ID: NCT06239051 Completed - Female Infertility Clinical Trials

Greening the Humanitas Fertility Center: How to Build a More Sustainable Medical Daily Routine

Green
Start date: September 18, 2023
Phase:
Study type: Observational

The goal of this observational study is to redefine an everyday clinical routine at the Humanitas Fertility center calculating the effects derived from the reduction of inappropriate and avoidable tests, procedures, tools and treatments currently used. Anonymized patients data about clinical procedures are used, taken from the internal database of the Humanitas fertility center

NCT ID: NCT06220227 Completed - Female Infertility Clinical Trials

The Embryologist's Impact on Blastocyst Vitrification and Thawing

Start date: January 1, 2019
Phase:
Study type: Observational

The goal of this monocentric retrospective observational study is to analyse, for the first time in literature, the role of the embryologist who freezes and thaws the embryos. The primary objective of the study is to understand whether the embryologist who freezes and thaws the embryo influences the CPR (clinical pregnancy rate). Secondary objectives, in case of statistically significant influence, are: - Evaluate who influences more the CPR, between the embryologist who freezes the embryos and the embryologist who thaws the embryos. - Evaluate if the embryologist who freezes and thaws the embryo impacts more than the embryologist or the physician who performs the ET. - Evaluate whether the embryologists improve their performances, as their experience increases. - Evaluate, through an external validation test, whether the model used can also be applied at other PMA centres The study will consider all the freezing (vitrifications) and thawing procedures, performed at Humanitas Fertility Center between January 2019 and June 2023. The study will include the transfers of single blastocysts, cryopreserved at Humanitas Fertility Center. On the other hand, the blastocysts transferred from other centres and the donor blastocysts will be excluded from the study, as well as multiple blastocysts transfers and the LP cycles. The embryologist's experience will be assessed in terms of number of previous cryopreservation (vitrification) and thawing procedures. We will include in the study all the embryologists who performed at least 50 freezing and thawing. For the evaluation of the study objectives, data will be gathered using a specific internal web-based database. The final model will be created by analysing the Humanitas Fertility Center dataset and validated using datasets extrapolated from similar population from the San Raffaele Hospital infertility centre

NCT ID: NCT06206746 Recruiting - Clinical trials for Polycystic Ovary Syndrome

The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue under Ultrasound Guidance in Women with Infertility due to Polycystic Ovary Syndrome

NCT ID: NCT06193135 Not yet recruiting - Infertility, Female Clinical Trials

Usefulness of Corifollitropin α as Alternative to Conventional Daily rFSH Protocols in Oocyte Donors Undergoing Pituitary Suppression With Medroxiprogesterona Acetate (MPA)

TROPIX
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

IVF patients frequently experience physical, emotional or physicological burden; this is particularly relevant in the case of oocyte donors, since young women undergo a procedure that is of no health benefit to them. One of the phases of the treatment that contributes most to this situation is ovarian stimulation; as it involves the administration of daily injections which, in addition to the discomfort of administration, causes anxiety to the patient about its correct administration and possible side effects and to physicians concerns about patient compliance. Advances in pharmacology and knowledge of ovarian pathophysiology have led to the development of new protocols that simplify and reduce drug administration, decrease the potential risk of misapplication and contribute to an improved patient experience. In this context, Corifollitropin α, a long-acting recombinant FSH (rFSH) molecule, provides with a single subcutaneous injection similar results as daily administration of rFSH during a week. On the other hand, conventional stimulation protocols used in ART resort to using a GnRH analogue (agonist or antagonist) to prevent early luteinization, which is defined as the presence of a progesterone value of > 1.5 ng/ml on the day of induced ovulation. Nevertheless, its use presents some disadvantages, such as it being sometimes complex to achieve desensitization or consistent hypothalamic block, risk of OHS when ovulation is triggered with HCG or its cost. Hence the interest in exploring new options to prevent a premature peak in LH. Nowadays, the oral administration of progestagens (progesterone-primed ovarian stimulation [PPOS]) during the follicular phase of ovarian stimulation (OS) has emerged as an attractive alternative to conventional protocols for preventing early luteinization. Moreover, PPOS produces a similar or even better, in some subgroups, response to OS (length of treatment, number of MII, cancelation rate, etc.), reproductive outcomes (pregnancy rate, live birth rate, etc) and safety (rate of ovarian hyperstimulation [OHSS] or congenital malformations). Thus, PPOS would seem to be an effective option for personalized protocols, particularly when fresh embryo transfer (FET) is not to be performed, a circumstance that is likely to rise in frequency given the progressive increase in women's age at childbearing; for example, in oocyte donation, or in fertility preservation (FP) and preimplantation genetic testing for aneuploidy (PGT-A). However, very little data are available regarding cycle outcome following Corifollitropin α and PPOS as pituitary suppressor. The present study, a prospective RCT, was designed to evaluate cycle characteristics (MII oocytes as the primary objective) and endocrinologic profiles of oocyte donors receiving Corifollitropin α and MPA as co-treatment compared with those receiving a daily dose of rFSH (follitropin β) as a control.

NCT ID: NCT06181890 Enrolling by invitation - Infertility, Female Clinical Trials

The Effect of Motivational Interviews

Start date: October 25, 2023
Phase:
Study type: Observational

The aim of the study was to determine the effect of motivational interviews applied to infertile women on their ability to cope with infertility, self-efficacy and stress.

NCT ID: NCT06174298 Recruiting - Infertility Clinical Trials

The Role of Granulocyte Colony Stimulating Factor in Embryo Transfer Outcomes

Start date: March 20, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to test the effect of granulocyte colony-stimulating factor (G-CSF, A.K.A. Filgrastim) in infertility patients undergoing in vitro fertilization (IVF) treatment. The main question it aims to answer is: Can in vitro fertilization-embryo transfer (IVF-ET) outcomes be improved by supplementing the transfer media with Granulocyte colony-stimulating factor (GCSF)? Participants will undergo their embryo transfer as per the normal clinic protocol but will be randomized to either receive the standard embryo transfer media or the GCSG-supplemented transfer media. Researchers will compare the GCSF and standard transfer media groups to see if clinical outcomes are improved (i.e., implantation rate, pregnancy, clinical pregnancy rate, live birth rate).

NCT ID: NCT06173869 Recruiting - Infertility, Female Clinical Trials

A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China

COCO
Start date: March 29, 2024
Phase: Phase 3
Study type: Interventional

This is a phase 3b clinical trial with follitropin delta (FE 999049) and Gonal-F. The trial is a randomised, controlled, assessor-blind, parallel groups, multicentre trial comparing the ovarian response of a starting dose of either 10mg or 15 mg follitropin delta to a starting dose of either 150 IU or 225 IU Gonal-F in a long GnRH agonist protocol in women undergoing an assisted reproductive technology programme in China.