Follicle Size and Oocyte Development

NCT03660813 | Completed

• 1 other identifier: 4689-17-SMC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Studies have shown that the follicles greater in diameter was most likely to have a mature oocyte that was capable of fertilization and best suited for development into a high-quality embryo. Smaller follicles showed lower rates ( 60%). Lately new triggering protocols have emerged aiming to improve the proportion of mature oocytes at the time of retrieval. The aim of this study is to learn the effects of the dual triggering compared to the standard hCG triggering on the oocyte development and quality as a function of the follicle size

Conditions

IVF Treatment

Keywords

oocyte, double triggering, follicle size

Outcome Measures

Primary Outcomes (1)

• Oocyte retrieved in each of the follicular size groups

  Number of oocyte retrieved in each of the follicular groups divided according to the maximal dimensional size

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Metaphase II oocytes (MII)

  Through study completion, an average of 1 year

• Fertilization rate

  Through study completion, an average of 1 year

• Top Quality Embryo

  Through study completion, an average of 1 year

Study Arms (2)

HCG triggering

EXPERIMENTAL

Ovitrelle ( hCG 250 mcg)

Diagnostic Test: Follicle measurment; Drug: Ovitrelle ( Hcg 250 mcg)

Dual triggering

EXPERIMENTAL

Ovitrelle ( Hcg 250 mcg) + Decapeptyl ( GnRH Agonist 0.1 mg\*2 )

Diagnostic Test: Follicle measurment; Drug: Ovitrelle ( Hcg 250 mcg); Drug: Decapeptyl ( GnRH Agonist 0.1 mg*2 )

Interventions

Follicle measurment DIAGNOSTIC_TEST

Follicle will be measured before aspiration

Dual triggering; HCG triggering

Ovitrelle ( Hcg 250 mcg) DRUG

Drug used for triggering

Dual triggering; HCG triggering

Decapeptyl ( GnRH Agonist 0.1 mg*2 ) DRUG

Drug used for triggering

Dual triggering

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only women during IVF treatment
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age- 18-45
• Antagonist protocol
• Triggering: A- with Ovitrelle ( HCG) 250 mcg B- with dual triggering - Ovitrelle ( HCG) 250 mcg + Decapeptyl ( GnRH Agonist ) 0.1 mg\*2

You may not qualify if:

• Endometriosis
• Known mutation of Fragile X

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Related Publications (5)

• Miller KF, Goldberg JM, Falcone T. Follicle size and implantation of embryos from in vitro fertilization. Obstet Gynecol. 1996 Oct;88(4 Pt 1):583-6. doi: 10.1016/0029-7844(96)00241-4.

  PMID: 8841223 RESULT

• Orvieto R. Triggering final follicular maturation-hCG, GnRH-agonist or both, when and to whom? J Assist Reprod Genet. 2016 Oct;33(10):1415-1416. doi: 10.1007/s10815-016-0775-4. Epub 2016 Jul 22. No abstract available.

  PMID: 27448022 RESULT

• Andersen CY. Characteristics of human follicular fluid associated with successful conception after in vitro fertilization. J Clin Endocrinol Metab. 1993 Nov;77(5):1227-34. doi: 10.1210/jcem.77.5.7521343.

  PMID: 7521343 RESULT

• Rosen MP, Shen S, Dobson AT, Rinaudo PF, McCulloch CE, Cedars MI. A quantitative assessment of follicle size on oocyte developmental competence. Fertil Steril. 2008 Sep;90(3):684-90. doi: 10.1016/j.fertnstert.2007.02.011. Epub 2008 Feb 4.

  PMID: 18249377 RESULT

• Bergh C, Broden H, Lundin K, Hamberger L. Comparison of fertilization, cleavage and pregnancy rates of oocytes from large and small follicles. Hum Reprod. 1998 Jul;13(7):1912-5. doi: 10.1093/humrep/13.7.1912.

  PMID: 9740448 RESULT

MeSH Terms

Interventions

Chorionic Gonadotropin; Thyrotropin Alfa; Triptorelin Pamoate

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins; Thyrotropin; Pituitary Hormones, Anterior; Pituitary Hormones; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Neuropeptides; Oligopeptides; Nerve Tissue Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: September 7, 2018
• Study Start: July 1, 2018
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)