Early Luteal Progesterone Profile in IVF Patients Triggered With hCG


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Verified May 2017 by Manh Tuong Ho, Vietnam National University

Sponsor:

Collaborator:

Mỹ Đức Hospital

Information provided by (Responsible Party):

Manh Tuong Ho, Vietnam National University

ClinicalTrials.gov Identifier:

NCT03174691

First received: May 30, 2017

Last updated: May 30, 2017

Last verified: May 2017

Until now very little information exists regarding the early luteal serum progesterone profile after Human chorionic gonadotropin (hCG) trigger. This pilot-study will help characterize the serum progesterone profiles in IVF patients and correlate progesterone levels to ovarian follicles obtained after stimulation with exogenous gonadotropins.

Progesterone Other: Blood collection

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:

IVF patients triggered with hCG

Masking: No masking
Primary Purpose: Treatment

Official Title: The Early Luteal Progesterone Profile in IVF Patients Triggered With hCG

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment: 130
Anticipated Study Start Date: June 7, 2017
Estimated Study Completion Date: April 1, 2018
Estimated Primary Completion Date: August 1, 2017 (Final data collection date for primary outcome measure)
Hormonal levels

Blood samples are collected for analysis of LH, E2, hCG and progesterone.

Other: Blood collection

A total of ten (10) blood samples (2ml/each) will be collected during the study.

Blood samples will be collected on the following days for subsequent analysis of LH, E2, hCG and progesterone.

The early luteal phase after IVF treatment is only scarcely studied (Ragni et al., 2001; Fauser et al., 2002; Beckers et al., 2003, Humaidan et al., 2012). During IVF treatment the early luteinizing hormone (LH) activity deficit induced after ovarian stimulation with exogenous gonadotropins will be partly covered by the bolus of hCG used for triggering of final oocyte maturation due to the long half-life of hCG (Weissman et al., 1996; Fauser et al., 2002; Andersen C.Y and Vilbour Andersen, 2014). In addition, the luteal phase will be covered by exogenous progesterone supplementation. After successful implantation the embryo itself will provide the supportive LH activity, securing the function of the corpora lutea. However, during early luteal phase and peri-implantation recent data suggest that an early-mid-luteal hCG/LH deficiency exists after hCG trigger during which the corpus luteum lacks an optimal stimulation (Andersen CY and Vilbour Andersen, 2014). Furthermore, the early luteal progesterone profile in IVF differs significantly from the progesterone profile of the natural cycle, in which the peak is reached around the time of implantation. With this non-invasive trial we wish to further explore the early luteal phase profiles of progesterone and hCG in order to optimize current luteal phase support policies in IVF and hopefully increase ongoing pregnancy rates.

Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Freeze all cycle after hCG trigger
  • Age 18 – 38
  • BMI < 28kg/m2
  • Normal ovarian reserve, defined by Anti-Mullerian Hormone (AMH) > 1.25 ng/ml or Antral Follicle Count (AFC) ≥ 6 measured within two months prior to stimulation start
  • Receiving gonadotrophin releasing hormone (GnRH) antagonist co-treatment during ovarian stimulation
  • Agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
  • Have given written informed consent with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

  • Previous poor response (≤ 3 oocytes) after high dose follicle stimulating hormone (FSH) stimulation
  • Hyper-response defined as >20 follicles ≥ 14 mm
  • Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B and Sexually Transmitted Diseases Simultaneous participation in an interventional clinical trial.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03174691

Vietnam National University

Mỹ Đức Hospital

Responsible Party: Manh Tuong Ho, Doctor, Vietnam National University
ClinicalTrials.gov Identifier: NCT03174691     History of Changes
Other Study ID Numbers: VietnamNU
Study First Received: May 30, 2017
Last Updated: May 30, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 02, 2017