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Infertility clinical trials

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NCT ID: NCT03738618 Recruiting - Infertility, Female Clinical Trials

Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-2)

RITA-2
Start date: October 29, 2018
Phase: Phase 3
Study type: Interventional

This trial investigates the effects of FE 999049 compared to placebo.

NCT ID: NCT03737253 Recruiting - Female Infertility Clinical Trials

Hormone Evaluation in Artificial Reproductive Technology

HEART
Start date: September 1, 2016
Phase: Phase 4
Study type: Interventional

The aim is to be able to predict the hormonal response according to gonadotropin receptor genotype and hormone type used for treatment of women undergoing in vitro fertilization or egg donation. Outcome will be measured as pregnancy success, live born babies and unwanted side effects.

NCT ID: NCT03735030 Not yet recruiting - Infertility Clinical Trials

Comparative Bioavailability Study of Human Chorionic Gonadotropin (hCG)-IBSA Versus a Marketed hCG Formulation

Start date: December 2018
Phase: Phase 1
Study type: Interventional

In the present study, the rate and extent of hCG absorption will be compared between the two treatments in healthy women aged 20 to 45 years.

NCT ID: NCT03731858 Not yet recruiting - Infertility Clinical Trials

HbA1c in Intracytoplasmic Sperm Injection

Start date: November 10, 2018
Phase:
Study type: Observational

ICSI has increased nowadays for treating cases of longstanding infertility . HbA1c has an important value in evaluating glucose level in blood

NCT ID: NCT03727971 Not yet recruiting - Asthma Clinical Trials

Pregnancy Rate, Asthma, Infertility, Omalizumab

PRO_ART
Start date: November 1, 2018
Phase: Phase 2
Study type: Interventional

The investigators have previously confirmed a clinical hunch that women with asthma have difficulties in becoming pregnant. The investigators found increased time to pregnancy (TTP) in women with asthma compared to non-asthmatic women (55 vs 33 months, p<0.001), furthermore, women with asthma had less successful pregnancies following fertility treatment (39.6 vs 60.4%, p=0.002). Treatment with omalizumab stabilizes the eosinophilic disease, through the systemic and most likely the anti-inflammatory pathways, which indicate a promising possibility to increase pregnancy rate. In a small real-life study in 2017, 5 patients with eosinophilic asthma who underwent in vitro fertilization (IVF), were treated with omalizumab prior to embryo transplantation; three out of the five women became pregnant. Lastly, the two remaining patients had several treatments with omalizumab, but did not become pregnant. This real-life study calls for further investigation. By targeting systemic inflammation with omalizumab treatment the aim is to increase asthma control before and during pregnancy. A treatment strategy aiming at improving overall inflammatory control may increase fertility, but also reduce well known maternal and perinatal adverse pregnancy outcomes such as pregnancy loss, preeclampsia, gestational diabetes, low-birth weight, small for gestational age (SGA), preterm delivery. Study design: A randomized control trial with omalizumab and placebo, stratified for blood eosinophil count, is therefore needed. A randomized, double blinded, parallel group, study to evaluate the difference between omalizumab (O) and placebo (P) on pregnancy rate in patients with atopic asthma.Treatment schedule: After collection of material (blood samples, sputum, secretion of the vagina, secretion of the rectum, microbiota) 6th day (±1 day) of the menstrual cycle, the patients will be randomized in either the omalizumab group or the placebo group. No collection of material will be done at the time of enrollment, as this will be on different time of the female cycles. The treatment is initiated with one injection with weight and serum-immunglobulin E balanced omalizumab or one injection placebo. After omalizumab treatment at ovulation it will again be collected material (blood samples, sputum, secretion of the vagina, secretion of the rectum, secretion of the uterus, microbiota). If no pregnancy has occurred after first IVF cycle, this will be repeated for 3 consecutive IVF cycles in total or until pregnancy has occurred. Outcome: The primary out-come is efficacy of omalizumab, compared to placebo, in increasing pregnancy rate in females with asthma. Secondary out-comes are changes in the inflammation in lungs/systemic/uterus, change in microbiota in the uterus and lungs, pregnancy loss, asthma control and biomarkers in the blood/lungs/uterus.

NCT ID: NCT03726450 Not yet recruiting - Male Infertility Clinical Trials

Myo-inositol and an Antioxidant Mix for the Treatment of Vietnamese Infertile Men

Start date: November 15, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate if Myo-inositol, N-Acetyl-Cysteine plus a cocktail of antioxidants could be able to increase spermatozoa parameters and reduce semen hyper-viscosity

NCT ID: NCT03725904 Recruiting - Infertility, Female Clinical Trials

Daytime Profile of Salivary Progesterone

Start date: October 24, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to perform a 12-hour profile of free saliva progesterone during the luteal phase after fresh and frozen embryo transfer. If progesterone levels in saliva samples show a constant level during daytime, this non-invasive measurement can be used in future ART patients with insufficient progesterone levels who might benefit from additional exogenous progesterone supplementation.

NCT ID: NCT03725280 Not yet recruiting - Infertility Clinical Trials

Micro RNA Profile in the Ovarian Follicle Fluid of Transgender Men

Start date: November 1, 2018
Phase:
Study type: Observational [Patient Registry]

The effects of gender transitioning, particularly the effects of testosterone exposure in transgender men, on the oocyte and embryo development are largely unknown. Based on prior studies suggesting that the extracellular RNAs secreted by the ovarian follicle cells reflect the oocyte and embryo biological state, the investigators propose to use these extracellular RNAs to gain insights into the effects of testosterone exposure in transgender men on their oocyte and embryo without impacting the clinical IVF process.

NCT ID: NCT03717870 Not yet recruiting - Infertility, Female Clinical Trials

Surgery and ART For Endometrioma

Start date: October 2019
Phase: N/A
Study type: Interventional

Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of endometrial-like tissue, glands and stroma outside the uterine cavity. Although endometriosis is classified in four stage (minimal, mild, moderate, severe), from the clinical point of view it is possible to subdivide among peritoneal superficial lesions, ovarian endometriomas and Deep Infiltrating Endometriosis (DIE). According to the European Society for Human Reproduction and Embryology (ESHRE) Guideline on the management of women with endometriosis, it is recommended to clinicians that in infertile women with endometrioma larger than 3 cm, cystectomy should be considered prior to Assisted Reproduction Technology (ART) to improve endometriosis-associated pain or the accessibility of follicles. They further recommend that clinicians counsel women with endometrioma regarding the risks of reduced ovarian function after surgery, the possible loss of the ovary, and consider that the decision to proceed with surgery should be taken carefully if the woman has had previous ovarian surgery. In addition, this Guideline suggests that clinicians can prescribe prolonged (3-6 months) pituitary downregulation with Gonadotropin Releasing Hormone-agonists (GnRH-a) prior to ART, in order to increase live birth rate by four-fold. Despite these recommendations, to date there is not robust evidence to choose between the two strategies prior to ART in order to improve reproductive outcomes. For this reason, the aim of the current study will be to compare reproductive outcomes in infertile women affected by ovarian endometrioma, undergoing laparoscopic enucleation or prolonged pituitary downregulation with GnRH-a, prior to ART.

NCT ID: NCT03717805 Not yet recruiting - Infertility Clinical Trials

The Evaluation of a Preparatory Information Movie on Oocyte Aspiration

POAM-RCT
Start date: October 29, 2018
Phase: N/A
Study type: Interventional

The Preparatory information on Oocyte Aspiration Movie Randomized Controlled Trial (POAM-RCT) primarily aims to evaluate whether a new preparatory information on oocyte aspiration movie (POAM) decreases the anxiety of women on the day of their first oocyte aspiration for in vitro fertilisation (IVF). The control group of this RCT will receive care as usual. The intervention group will additional be given access to a preparatory information movie on oocyte aspiration 1-3 days before their oocyte aspiration via a secured link. Women's anxiety will be assessed with the 'State module of the State Trait Anxiety Inventory (STAI-state)' upon arrival at the fertility clinic on the day of the oocyte aspiration. At the same time other questionnaires will be administered. More specifically, men's anxiety and both partner's infertility specific distress will be assessed. In addition, to these secondary outcomes, clinical pregnancy with fetal heart beat and miscarriage will be followed-up 12 weeks after the oocyte aspiration. Finally, treatment delay and treatment discontinuation and long-term clinical outcomes (i.e. live birth from the first fresh embryo transfer, clinical pregnancy with fetal heart beat from the frozen embryo transfers of 1st IVF-cycle and the 12-months cumulative clinical pregnancy rates) will be followed-up twelve months after oocyte aspiration. This RCT will include 190 women (and their male partners) treated with a 1st cycle of IVF (with or without ICSI and PGD). Analysis will be according to intention to treat.