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Protocol to Minimize Injections and Blood Draws for Women Undergoing in Vitro Fertilization

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Menopur
Synarel
HCG trigger
Clomiphene citrate
Letrozole
Sponsored by
New Hope Fertility Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility focused on measuring Infertility, Gonadotropins, Menopur, Ovarian stimulation

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age range: 18-45. The participant should be a woman of reproductive age, i.e., premenopausal who is healthy.
  2. Body mass index: 19-35 kg/m2
  3. Diagnosis of infertility: inability to conceive with unprotected intercourse after 1 year for women aged < 35 and after 6 months for women aged > 35.
  4. Pap smear within 1 year should be normal.
  5. Endometrial cavity will be evaluated and should be normal using hysteroscopy or saline ultrasound
  6. Fallopian tubes will be assessed by hysterosalpingogram in women who have normal ovarian reserve, regular menstrual cycles with a partner who has normal semen analysis. Unless there is a clear diagnosis of a reason for infertility, such as poor sperm, poor ovarian reserve, fallopian tube patency will not be performed because it would not change the treatment.
  7. Semen analysis will be performed on every male partner to ensure that there are sperm to be used for IVF/ICSI.
  8. All assessment will be performed at baseline and before initiation of any treatment.
  9. The investigators will obtain at screening Pap smear, hysteroscopy or saline ultrasound, hysterosalpingography, and semen analysis if they have not been done within one year of baseline.

Exclusion Criteria:

  1. Any medical condition that interferes with the health of the participant such as uncontrolled diabetes, uncontrolled hypertension, cardiac disease, or renal disease.
  2. Any type of malignancy.
  3. Mental problems that could interfere with the patient's ability to conceive and take care of her baby.
  4. Abnormal endometrial cavity that could interfere with implantation and/or carrying the pregnancy.

Sites / Locations

  • New Hope Fertility Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional IVF

IVF protocol using nasal gonadotropins

Arm Description

Conventional ovarian stimulation consist of ovarian stimulation with daily gonadotropins injections daily starting in the early follicular phase (cycle day 3). The final maturation of oocytes will be induced with the standard hCG trigger when at least two follicles reached 18 mm or greater. Oocyte retrieval will be performed by either local or general anesthesia depending on the ovarian response, i.e., the number of mature follicles. Retrieved oocytes will be fertilized by IVF/ICSI and subsequently cultured until the blastocyst stage. All blastocysts will be vitrified. A single thawed blastocyst will be transferred in a subsequent natural or artificially prepared cycle.

Instead of injectable gonadotropins, nasal human menopausal gonadotropins (hMG; menopur) and oral clomiphene citrate and/or oral letrozole starting in the early follicular phase (cycle day 3). When at least two follicles reached 18 mm or greater, Synarel (Nafarelin) will be used instead of the injectable HCG trigger. Oocyte retrieval will be performed by either local or general anesthesia depending on the ovarian response, i.e., the number of mature follicles. Retrieved oocytes will be fertilized by IVF/ICSI and subsequently cultured until the blastocyst stage. All blastocysts will be vitrified. A single thawed blastocyst will be transferred in a subsequent natural or artificially prepared cycle.

Outcomes

Primary Outcome Measures

Serum estradiol level
serum estradiol level in pg/mL as representative of ovarian response
Ovarian follicular size
Pelvic ultrasound to measure the size of each ovarian follicle as representative of ovarian response

Secondary Outcome Measures

Adverse Events That Are Related to Nasal Menopur Treatment
whether there are any side effects

Full Information

First Posted
July 14, 2016
Last Updated
March 15, 2019
Sponsor
New Hope Fertility Center
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1. Study Identification

Unique Protocol Identification Number
NCT02865681
Brief Title
Protocol to Minimize Injections and Blood Draws for Women Undergoing in Vitro Fertilization
Official Title
Protocol to Minimize Injections and Blood Draws for Women Undergoing Controlled Ovarian Hyperstimulation for in Vitro Fertilization
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
June 7, 2017 (Actual)
Study Completion Date
June 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New Hope Fertility Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to evaluate the safety and efficacy of nasal gonadotropins (Menopur) in women undergoing IVF. The purpose of this study is also to report and monitor any and all side effects of the nasal Menopur.
Detailed Description
Gonadotropins are used during fertility treatments such as intrauterine insemination (IUI) or in vitro fertilization (IVF). These fertility medications are given by injection that contain follicle-stimulating hormone (FSH) alone or combined with luteinizing hormone (LH). During a regularly occurring menstrual cycle, both FSH and LH are produced by the pituitary gland in the brain to naturally stimulate the ovaries to make a single egg each month. When FSH and/or LH are given as an injection as fertility treatment, they work directly on the ovaries to make multiple follicles which are cysts containing the eggs. Injections of gonadotropins are started early (usually on the third day) in the menstrual cycle to cause multiple eggs to grow to a mature size. Close monitoring of patients with ultrasound and blood are usually needed for monitoring. The ultrasound measures the size of the ovarian follicles. Blood is usually drawn every other day or daily (for a total of 12 days on average) for measurement of Estradiol (E2), progesterone (P4), and luteinizing hormone (LH). The measurement of E2, P4 and LH is intended to quantify the response of the ovaries to the daily injectable gonadotropins. When the follicles grow to a large size (usually 18 mm), human chorionic gonadotropin (hCG), another injectable medication, is then used to trigger the maturity of the eggs before performing egg retrieval during an IVF cycle. Instead of injectable gonadotropins, this study uses nasal gonadotropins (Menopur) in order to evaluate its safety and efficacy of in women undergoing IVF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, Gonadotropins, Menopur, Ovarian stimulation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional IVF
Arm Type
Active Comparator
Arm Description
Conventional ovarian stimulation consist of ovarian stimulation with daily gonadotropins injections daily starting in the early follicular phase (cycle day 3). The final maturation of oocytes will be induced with the standard hCG trigger when at least two follicles reached 18 mm or greater. Oocyte retrieval will be performed by either local or general anesthesia depending on the ovarian response, i.e., the number of mature follicles. Retrieved oocytes will be fertilized by IVF/ICSI and subsequently cultured until the blastocyst stage. All blastocysts will be vitrified. A single thawed blastocyst will be transferred in a subsequent natural or artificially prepared cycle.
Arm Title
IVF protocol using nasal gonadotropins
Arm Type
Experimental
Arm Description
Instead of injectable gonadotropins, nasal human menopausal gonadotropins (hMG; menopur) and oral clomiphene citrate and/or oral letrozole starting in the early follicular phase (cycle day 3). When at least two follicles reached 18 mm or greater, Synarel (Nafarelin) will be used instead of the injectable HCG trigger. Oocyte retrieval will be performed by either local or general anesthesia depending on the ovarian response, i.e., the number of mature follicles. Retrieved oocytes will be fertilized by IVF/ICSI and subsequently cultured until the blastocyst stage. All blastocysts will be vitrified. A single thawed blastocyst will be transferred in a subsequent natural or artificially prepared cycle.
Intervention Type
Drug
Intervention Name(s)
Menopur
Other Intervention Name(s)
gonadotropin
Intervention Description
Nasal versus injectable
Intervention Type
Drug
Intervention Name(s)
Synarel
Other Intervention Name(s)
GnRH agonist
Intervention Description
nasal
Intervention Type
Drug
Intervention Name(s)
HCG trigger
Other Intervention Name(s)
HCG
Intervention Description
injectable
Intervention Type
Drug
Intervention Name(s)
Clomiphene citrate
Other Intervention Name(s)
Clomid
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
Femara
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Serum estradiol level
Description
serum estradiol level in pg/mL as representative of ovarian response
Time Frame
1 year
Title
Ovarian follicular size
Description
Pelvic ultrasound to measure the size of each ovarian follicle as representative of ovarian response
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse Events That Are Related to Nasal Menopur Treatment
Description
whether there are any side effects
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age range: 18-45. The participant should be a woman of reproductive age, i.e., premenopausal who is healthy. Body mass index: 19-35 kg/m2 Diagnosis of infertility: inability to conceive with unprotected intercourse after 1 year for women aged < 35 and after 6 months for women aged > 35. Pap smear within 1 year should be normal. Endometrial cavity will be evaluated and should be normal using hysteroscopy or saline ultrasound Fallopian tubes will be assessed by hysterosalpingogram in women who have normal ovarian reserve, regular menstrual cycles with a partner who has normal semen analysis. Unless there is a clear diagnosis of a reason for infertility, such as poor sperm, poor ovarian reserve, fallopian tube patency will not be performed because it would not change the treatment. Semen analysis will be performed on every male partner to ensure that there are sperm to be used for IVF/ICSI. All assessment will be performed at baseline and before initiation of any treatment. The investigators will obtain at screening Pap smear, hysteroscopy or saline ultrasound, hysterosalpingography, and semen analysis if they have not been done within one year of baseline. Exclusion Criteria: Any medical condition that interferes with the health of the participant such as uncontrolled diabetes, uncontrolled hypertension, cardiac disease, or renal disease. Any type of malignancy. Mental problems that could interfere with the patient's ability to conceive and take care of her baby. Abnormal endometrial cavity that could interfere with implantation and/or carrying the pregnancy.
Facility Information:
Facility Name
New Hope Fertility Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
will share the data upon request
Citations:
PubMed Identifier
30500132
Citation
Zhang J, Merhi Z. Safety data for the use of nasal human menopausal gonadotropins: a potential novel approach for fertility treatment. JBRA Assist Reprod. 2019 Apr 30;23(2):169-171. doi: 10.5935/1518-0557.20180078.
Results Reference
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Protocol to Minimize Injections and Blood Draws for Women Undergoing in Vitro Fertilization

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