InfertilityNCT02865681
Protocol to Minimize Injections and Blood Draws for Women Undergoing in Vitro Fertilization
A study testing Menopur, Synarel and HCG trigger in people with Infertility, run by New Hope Fertility Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Menopur, Synarel and HCG trigger
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 7 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol to Minimize Injections and Blood Draws for Women Undergoing Controlled Ovarian Hyperstimulation for in Vitro Fertilization
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Menopur, Synarel, HCG trigger, Clomiphene citrate, Letrozole
- Keywords
- Infertility, Gonadotropins, Menopur, Ovarian stimulation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenopurDrug
Also called gonadotropin
Nasal versus injectable
SynarelDrug
Also called GnRH agonist
nasal
HCG triggerDrug
Also called HCG
injectable
Clomiphene citrateDrug
Also called Clomid
oral
LetrozoleDrug
Also called Femara
Oral
| Study group | Role | What they receive |
|---|---|---|
| Conventional IVF | Active comparator | 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. Receives: Drug: Menopur; Drug: Synarel; Drug: HCG trigger; Drug: Clomiphene citrate; Drug: Letrozole |
| IVF protocol using nasal gonadotropins | Experimental | 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. Receives: Drug: Menopur; Drug: Synarel; Drug: Clomiphene citrate; Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum estradiol level
serum estradiol level in pg/mL as representative of ovarian response
Measured: 1 year
Ovarian follicular size
Pelvic ultrasound to measure the size of each ovarian follicle as representative of ovarian response
Measured: 1 year
Secondary outcomes (1)
Adverse Events That Are Related to Nasal Menopur Treatment
whether there are any side effects
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start1 Jul 2016
- Primary completion7 Jun 2017
- Study completion7 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Hope Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaher Merhi, New Hope Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865681
- Sponsor's protocol ID
- JZ08-15
- Status last verified
- Mar 2019
- First submitted
- 14 Jul 2016
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will share the data upon request
Publications
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.
PubMed 30500132
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol to Minimize Injections and Blood Draws for Women Undergoing Controlled Ovarian Hyperstimulation for in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT02865681
- Acronym / sponsor ID
- JZ08-15
- Conditions
- Infertility
- Keywords
- Infertility, Gonadotropins, Menopur, Ovarian stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- New Hope Fertility CenterUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 7 Jun 2017 (actual)
- Study completion
- 7 Jun 2017 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional IVF | Active comparator | Drug: Menopur, Drug: Synarel, Drug: HCG trigger, Drug: Clomiphene citrate, Drug: LetrozoleConventional 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. |
| IVF protocol using nasal gonadotropins | Experimental | Drug: Menopur, Drug: Synarel, Drug: Clomiphene citrate, Drug: LetrozoleInstead 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MenopurAlso: gonadotropinNasal versus injectable | Drug | Conventional IVF, IVF protocol using nasal gonadotropins |
| SynarelAlso: GnRH agonistnasal | Drug | Conventional IVF, IVF protocol using nasal gonadotropins |
| HCG triggerAlso: HCGinjectable | Drug | Conventional IVF |
| Clomiphene citrateAlso: Clomidoral | Drug | Conventional IVF, IVF protocol using nasal gonadotropins |
| LetrozoleAlso: FemaraOral | Drug | Conventional IVF, IVF protocol using nasal gonadotropins |
Primary outcome
Serum estradiol level
Time frame: 1 year
serum estradiol level in pg/mL as representative of ovarian response
Ovarian follicular size
Time frame: 1 year
Pelvic ultrasound to measure the size of each ovarian follicle as representative of ovarian response
1 secondary outcome
Adverse Events That Are Related to Nasal Menopur Treatment
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Results publication: PubMed 30500132Zhang 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.
- Individual participant dataSharing planned: Undecided. will share the data upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menopur, Synarel and HCG trigger in people with Infertility, run by New Hope Fertility Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum estradiol level (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02865681, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.