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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 [1358 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 [1748 Associated PubMed Articles listed on BioPortfolio]

Ovarian stimulation with corifollitropin alfa followed by hp-hMG compared to hp-hMG in patients at risk of poor ovarian response undergoing ICSI: A randomized controlled trial.

To compare the results of two ovarian stimulation protocols for IVF in patients at risk of poor ovarian response: corifollitropin alfa followed by hp-hMG versus daily administration of hp-hMG. We inte...

A pilot study comparing corifollitropin alfa associated with hp-HMG versus high dose rFSH antagonist protocols for ovarian stimulation in poor responders.

Does corifollitropin alfa associated with hp-HMG protocol from the beginning of ovarian stimulation perform better than high dose rFSH alone for ovarian stimulation with GnRH antagonist in poor respon...

Safety of Follitropin Alfa/Lutropin Alfa for Stimulation of Follicular Development.

Recombinant human luteinizing hormone (r-hLH) is used in a fixed-ratio combination with recombinant human follicle-stimulating hormone (r-hFSH) for the stimulation of follicular development.

Association of progesterone production with serum anti-Müllerian hormone levels in assisted reproductive technology cycles with corifollitropin alfa.

The use of corifollitropin alfa (CA) in assisted reproductive technology (ART) cycles is dependent on the antral follicle count and body weight of patients. The present study investigated the safety a...

Comparing Therapeutic Efficacy and Safety of Epoetin Beta and Epoetin Alfa in the Treatment of Anemia in End-Stage Renal Disease Hemodialysis Patients.

Anemia is one of the most prevalent complications in patients with chronic kidney disease, which is believed to be caused by the insufficient synthesis of erythropoietin by the kidney. This phase III ...

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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