Implantation, EmbryoNCT01424618
A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs
A study testing Leuprolide and Ganirelix in people with Implantation, Embryo, run by Kelly, Maureen, M.D. at 1 site in United States.
Trial summary
This study compares two different methods to prepare the uterine lining of recipients for implantation in cycles using donor eggs. The study method requires less time than the standard method. It is hypothesized that both methods would be suitable for use in egg donor cycles. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Implantation, Embryo
- What is being tested?
- Leuprolide and Ganirelix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Sep 2012
- 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 52 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- recipients awaiting egg donation
- some ovarian function
- normal endometrial cavity
Who cannot join
- submucosal myoma
- myoma(s) greater than 4 centimeters
- endometrial polyp
- DES exposure
- documented recalcitrant thin endometrium ( <7 mm)
- untreated vulvovaginitis
Show all 17Show fewer
- active pelvic infection
- endometrial cancer or suspected/known hormonally sensitive cancers
- breast cancer
- thromboembolic disease
- cerebrovascular or coronary heart disease
- diabetes mellitus
- hepatic tumors or active liver disease
- severe hypertension
- headaches with neurologic disease
- cholestatic disease
- heavy smoking over age 35
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Society Hill Reproductive Medicine
Philadelphia, Pennsylvania, 19107
Dana Tillotson, BSN, 215-829-8110, dtillotson@reproductivemedicinepa.com
Maureen Kelly, MD
About this study
Official title: A Novel Approach to Endometrial Preparation in Recipients of Donor Cycles
This study compares two different methods to prepare the uterine lining of recipients for implantation in cycles using donor eggs. The study method requires less time than the standard method.
It is hypothesized that both methods would be suitable for use in egg donor cycles.
Read the detailed description
Currently a combination of medications is used to prepare the uterine lining of recipients for implantation in egg donor cycles. The protocol used most commonly is as follows: Initially the individual's own pituitary-ovarian system is suppressed using a GnRH agonist so there are not conflicting signals sent to the uterus. This is followed by hormonal medication identical to what is secreted by the ovaries to prepare the uterine lining for subsequent embryo transfer in donor egg cycles.This preparation typically takes a minimum of four weeks.
This study will compare a different medication, a GnRh antagonist (which is commonly used in IVF) to suppress an individual's system during the preparation of the uterine lining. This protocol would generally take only two weeks to prepare the uterine lining.
- Conditions
- Implantation, Embryo
- Being tested
- Leuprolide, Ganirelix
- Keywords
- Donor eggs, Donor oocytes, Pregnancy, Embryo Implantation, Infertility, IVF
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeuprolideDrug
Also called Lupron
leuprolide 10 units daily, decreased to 5 units daily once suppression achieved for a total of approximately 4 weeks. Once suppression achieved, estradiol and progesterone administered to mature uterine lining.
GanirelixDrug
Also called Antagon
Ganirelix 250 mcg daily will be used to suppress pituitary-ovarian function and is administered concurrently with estradiol and progesterone for approximately two weeks.
| Study group | Role | What they receive |
|---|---|---|
| GnRh agonist | Active comparator | This arm will use a GnRH agonist to suppress pituitary-ovarian function Receives: Drug: Leuprolide |
| GnRH antagonist | Experimental | A GnRH antagonist will be used to suppress pituitary-ovarian function Receives: Drug: Ganirelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrial thickness measured by ultrasound
In office ultrasound to measure thickness of endometrial lining.
Measured: 2-4 weeks
Secondary outcomes (1)
endometrial biopsy
In office aspiration of endometrial cells will be examined microscopically to determine if they are at an appropriate stage for implantation.
Measured: 3-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startJan 2006
- Primary completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implantation, EmbryoStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kelly, Maureen, M.D.
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Maureen Kelly, M.D., Kelly, Maureen, M.D.
- Investigators
- Maureen Kelly, MD, Principal investigator, Society Hill Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424618
- Sponsor's protocol ID
- 39604
- Status last verified
- Aug 2011
- First submitted
- 25 Aug 2011
- Last updated
- 29 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Endometrial Preparation in Recipients of Donor Cycles
- ClinicalTrials.gov ID
- NCT01424618
- Acronym / sponsor ID
- 39604
- Conditions
- Implantation, Embryo
- Keywords
- Donor eggs, Donor oocytes, Pregnancy, Embryo Implantation, Infertility, IVF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kelly, Maureen, M.D.
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2006
- Primary completion
- Sep 2012 (estimated)
- First posted
- 29 Aug 2011 (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.
This study compares two different methods to prepare the uterine lining of recipients for implantation in cycles using donor eggs. The study method requires less time than the standard method.
It is hypothesized that both methods would be suitable for use in egg donor cycles.
Detailed description
Currently a combination of medications is used to prepare the uterine lining of recipients for implantation in egg donor cycles. The protocol used most commonly is as follows: Initially the individual's own pituitary-ovarian system is suppressed using a GnRH agonist so there are not conflicting signals sent to the uterus. This is followed by hormonal medication identical to what is secreted by the ovaries to prepare the uterine lining for subsequent embryo transfer in donor egg cycles.This preparation typically takes a minimum of four weeks.
This study will compare a different medication, a GnRh antagonist (which is commonly used in IVF) to suppress an individual's system during the preparation of the uterine lining. This protocol would generally take only two weeks to prepare the uterine lining.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRh agonist | Active comparator | Drug: LeuprolideThis arm will use a GnRH agonist to suppress pituitary-ovarian function |
| GnRH antagonist | Experimental | Drug: GanirelixA GnRH antagonist will be used to suppress pituitary-ovarian function |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- recipients awaiting egg donation
- some ovarian function
- normal endometrial cavity
Key exclusion criteria (17 listed)
- submucosal myoma
- myoma(s) greater than 4 centimeters
- endometrial polyp
- DES exposure
- documented recalcitrant thin endometrium ( <7 mm)
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 |
|---|---|---|
| LeuprolideAlso: Lupronleuprolide 10 units daily, decreased to 5 units daily once suppression achieved for a total of approximately 4 weeks. Once suppression achieved, estradiol and progesterone administered to mature uterine lining. | Drug | GnRh agonist |
| GanirelixAlso: AntagonGanirelix 250 mcg daily will be used to suppress pituitary-ovarian function and is administered concurrently with estradiol and progesterone for approximately two weeks. | Drug | GnRH antagonist |
Primary outcome
endometrial thickness measured by ultrasound
Time frame: 2-4 weeks
In office ultrasound to measure thickness of endometrial lining.
1 secondary outcome
endometrial biopsy
Time frame: 3-6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2011.
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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.
Maureen Kelly, MD principal investigator
Society Hill Reproductive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leuprolide and Ganirelix in people with Implantation, Embryo, run by Kelly, Maureen, M.D. 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 3 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 29 Aug 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dana Tillotson, BSN (215-829-8110, dtillotson@reproductivemedicinepa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endometrial thickness measured by ultrasound (time frame: 2-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2011.