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Optimal Infertility Therapy RCT: Women 40 and Older

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Trial Conditions
  • Infertility
What is the purpose of this trial?

This study will determine the most effective treatment strategy for infertile couples who present when the female partner is 38 years to the 43rd birthday and the couples are determined to have a reasonable chance for success.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
38  - 43 

Gender:
Both

Eligibility

Inclusion criteria:

- Female partner age from 38th to the 43rd birthday at the time of recruitment and six
months of infertility.

- Male partner has a normal semen analysis showing at least 15 million total motile
sperm/ejaculate and at least 1% normal forms by strict criteria, or at least 5
million total motile sperm in an IUI prep.

- Patients must have at least one ovary and at least one ipsilateral patent fallopian
tube confirmed by HSG or laparoscopy. Pelvic pathology may be present but must be
amenable to operative laparoscopy with the pelvis restored to a functional state,
including surgically corrected stages I and II endometriosis. Patients with stage
III endometriosis qualify only if the disease is limited to an isolated endometrioma
in one or both ovaries and once removed the pelvis is restored to a functional state.
For patients with a single patent fallopian tube, the open tube cannot have had a
previous ectopic (tubal) pregnancy, and the closed tube cannot be a hydrosalpinx (a
tube that is blocked at the end and filled with fluid), unless a cauterization has
been performed at the junction of the uterus and fallopian tube. Alternatively, that
tube could be removed.

- 4. Normal uterine cavity demonstrated by HSG, sonohysterogram (SHG), or hysteroscopy;
pathology of the uterine cavity amenable to operative hysteroscopy (cavity restored
to normal and demonstrated by postoperative study).

- Regular menstrual cycles ranging from 21 - 45 days (patients with occasional cycles,
i.e. 1 -2 /year, outside this range will be acceptable).

- Acceptable ovarian reserve demonstrated in all patients by a clomiphene challenge
test, i.e., cycle day 3 FSH/E2 values of <15 mIU/mL and <100 pg/mL, respectively, and
cycle day 10 FSH < 15 mIU/ml. (Note: normal ovarian reserve is represented by FSH
values less than 10-12 mIU/mL; our acceptable values represent the transition zone.)
Normal TSH and prolactin levels.

- Informed consent from both partners.

- Female body mass index ≤ 38.

Exclusion Criteria:

- Previous tubal or uterine cavity reconstructive surgery in which the pelvis or
uterine cavity was not restored to functional.

- Unilateral or bilateral hydrosalpinx (a tube that is blocked at the end and filled
with fluid) that has not had a cauterization performed at the junction of the uterus
and fallopian tubes, or previous removal of a fallopian tube or an ovary.

- A laparoscopy that demonstrated pelvic adhesions or stage I or II endometriosis for
which the pelvis could not be restored to normal by surgery, or endometriosis that
was not ablated or excised. All patients with stage IV endometriosis, and those with
stage III unless the disease is limited to an isolated endometrioma in one or both
ovaries and once removed the pelvis is restored to a functional state.

- One or more prior ectopic pregnancies in which both affected tubes were rendered
nonfunctional. One ectopic pregnancy if it existed in the single remaining tube.
Two or more ectopic pregnancies even if both tubes are patent.

- Severe male factor (i.e. semen analysis not meeting criteria listed above). Couples
using donor semen will be excluded

- Previous treatment with IUI or IVF or for normal ovulatory patients with
gonadotropins.

- Inadequate ovarian reserve demonstrating FSH 15 mIU/mL or higher on cycle days 3 or
10 or estradiol 100 pg/mL or higher on cycle day 3.

- Anovulatory patients or those whose cycles are routinely < 21 days or > 45 days in
length.

- Patients requiring gamete intrafallopian tube transfer (GIFT), zygote intrafallopian
tube transfer (ZIFT), or tubal embryo transfer (TET).

- BMI greater than 38.

Gender: Both
Steward Physician(s)
  • Richard H. Reindollar, M.D.
Trial Interventions
Procedure
  • intrauterine insemination
  • in vitro fertilization
Physician Researcher

Investigator Name:

  • Richard H. Reindollar, M.D.

Other Information

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phase: N/A
Trial ID: NCT00246506
Volunteers:  Accepting Healthy Volunteers

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