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Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (Study P06031)

2014-08-27 03:12:49 | BioPortfolio

Summary

The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after the embryos are cryopreserved in P06029, which is a study in which single injection of SCH 900962 is compared with daily recFSH injections in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Conditions

Infertility

Intervention

SCH 900962 / Corifollitropin alfa / Org 36286, RecFSH / follitropin beta

Location

Investigational Site 1
Encino
California
United States
91436

Status

Recruiting

Source

Schering-Plough

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:49-0400

Clinical Trials [1301 Associated Clinical Trials listed on BioPortfolio]

A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)

To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa (Organon 36286) to induce multifollicular development for controlled ovarian stimulation using ...

Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)

The purpose of this study is to show that a single injection of SCH 900962/MK-8962 is non-inferior to daily injections of recombinant follicle-stimulating hormone (recFSH) during the first...

A Phase 2 Trial to Evaluate if Org 36286 (Corifollitropin Alfa), Followed by a Low Daily Dose of hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility (Study 107010)(TERMINATED)(P05693)

The primary objective of this trial is to evaluate whether an Org 36286 regimen applying a single or repeated dose of Org 36286 followed by a low daily dose of hCG or recFSH can induce mon...

To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(Study 107012)(COMPLETED)(P05690)

Clinical trial objectives are to investigate the efficacy and safety of a single injection of 100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for co...

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 107010 (Study 107011)(COMPLETED)(P05713)

The objective of this trial is to evaluate whether Org 36286 treatment for the induction of monofollicular growth in women undergoing ovulation induction (OI) is safe for pregnant subjects...

PubMed Articles [1677 Associated PubMed Articles listed on BioPortfolio]

Performance of prognostic modelling of high and low ovarian response to ovarian stimulation for IVF.

What is the performance of previously established regression models in predicting low and high ovarian response to 150 μg corifollitropin alfa/GnRH-antagonist ovarian stimulation in an independent da...

A strategy to reduce inflammation and anemia treatment's related costs in dialysis patients.

This is a post-hoc analysis evaluating erythropoiesis stimulating agents' (ESA) related costs while using an additional ultrafilter (Estorclean PLUS) to produce ultrapure dialysis water located within...

An easy-to-use baseline scoring system to predict response to peginterferon alfa-2a in patients with chronic hepatitis B in resource-limited settings.

Approximately one-third of patients have durable responses after finite (48-week) treatment with peginterferon alfa-2a. The ability to identify patients likely to respond would be particularly useful ...

Changes in in vivo confocal microscopic findings of ocular surface squamous neoplasia during treatment with topical interferon alfa-2b.

To evaluate in vivo confocal microscopy (IVCM) findings of ocular surface squamous neoplasia (OSSN) during treatment with topical interferon alfa-2b (IFN alfa-2b).

Immune tolerance induction rescue with turoctocog-alfa in a poor risk haemophilia A inhibitor young child: the history of a success.

: The development of alloantibodies against the replacement of Factor VIII (FVIII) is the major complication in haemophilia A treatment. The gold standard to eradicate inhibitors is the immune toleran...

Medical and Biotech [MESH] Definitions

The beta subunit of luteinizing hormone. It is a 15-kDa glycopolypeptide with structure similar to the beta subunit of the placental chorionic gonadatropin (CHORIONIC GONADOTROPIN, BETA SUBUNIT, HUMAN) except for the additional 31 amino acids at the C-terminal of CG-beta. Full biological activity of LH requires the non-covalently bound heterodimers of an alpha and a beta subunit. Mutation of the LHB gene causes HYPOGONADISM and infertility.

A recombinant alfa interferon consisting of 165 amino acids with arginine at positions 23 and 34. It is used extensively as an antiviral and antineoplastic agent.

A recombinant alfa interferon consisting of 165 amino acids with lysine at position 23 and histidine at position 34. It is used extensively as an antiviral and antineoplastic agent.

A recombinant alfa interferon consisting of 165 amino acid residues with arginine in position 23 and histidine in position 34. It is used extensively as an antiviral and antineoplastic agent.

A highly purified recombinant glycoprotein form of human THYROID-STIMULATING HORMONE, produced by recombinant DNA technology comprising two non-covalently linked subunits, an alpha subunit of 92 amino acid residues containing two N-linked glycosylation sites, and a beta subunit of 118 residues containing one N-linked glycosylation site. The amino acid sequence of thyrotropin alfa is identical to that of human pituitary thyroid stimulating hormone.

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