An Oakland, Calif., woman and her long-term partner wanted to start a family.
She did not want to have heterosexual intercourse, nor did she want to use a medical intermediary -- like a sperm bank or doctor -- and pay a fee to get pregnant.
Instead, she wanted to use a free sperm sample from a man she had chosen, and inseminate herself.
However, FDA regulations state that "any establishment that performs one or more manufacturing steps" for donating sperm samples -- from producing a sample, having it analyzed, storing it, to providing it to a recipient -- must register with the agency and get tested for communicable diseases that may be transmitted through artificial insemination.
These regulations may also apply to uncompensated donors, like the one she and her partner sought out.
After the recent cease order issued by the FDA to Trent Arsenault, a free sperm donor from Acampo, Calif., ordering him to stop "manufacturing" and supplying couples with sperm who are seeking to get pregnant, the woman wanted to err on the side of caution.
As a result, she is suing, under the name Jane Doe, the commissioner of the U.S. Federal Drug Administration (FDA) and the secretary of the U.S. Department of Health and Human Services, claiming its regulations violate her rights to privacy for telling her how she should be allowed to conceive a child.
"This means the FDA can reach into your bedroom and tell you how to procreate," said her lawyer, Amber Abbasi, chief counsel for regulatory affairs at government accountability advocacy organization Cause of Action.
"The FDA taking the position that donors, even when there's no commercial element, are 'an establishment,' just like a sperm bank and have to register," said Abbasi, "this is a serious burden on the reproductive freedoms of both the recipient and the donor."
Abbasi said her client wanted to obtain fresh donor sperm from an individual she selected and implant it herself in a process known as intracervical artificial insemination -- injecting the semen into her cervix -- using a syringe, which does not require medical supervision.
According to the lawsuit, Doe felt it was important for the biological father to be present in her child's life, if he or she so desired. Doe did not want to visit a sperm bank for an anonymous sample, a process noted to be "costly and burdensome" for couples looking to get pregnant.
Doe had selected a donor and did a review on his personal and medical history before attempting to conceive through intracervical insemination, said the suit. She did get pregnant, but she miscarried.
Doe wants to try again, but is concerned that "her choices of conception partner and method of conception are directly barred by FDA regulations," and is worried she will be charged with a federal crime if she opts to get pregnant in the way that she wants to, according to the lawsuit.
"It is a real problem for [the FDA] to treat women like Ms. Doe, who has to become pregnant by artificial insemination because she's in a lesbian relationship," said Abbasi.
Abbasi said the difference between homosexual and heterosexual couples getting pregnant in the government's view is that there is a syringe involved.
Doe's suit was filed in U.S. District Court for the Northern District of California on July 2. Abbasi said the FDA has not responded, and no court date has been set yet.
"This is the first lawsuit of its kind," said Mary Beth Hutchins, communications director for Cause of Action.
FDA spokeswoman Rita Chappelle told ABC News she could not comment on pending litigation.
"Every day that the FDA is enforcing these regulations and prohibiting her from procreative conduct she's chosen for herself is a day that her biological clock is ticking away," Abbasi said.
"What the FDA is trying to do is protect the people, that's their job," said Dr. Mitch Rosen, director of the University of California at San Francisco fertility preservation center and the director of the University of California- San Francisco reproduction laboratories.
Rosen said that while paying fertility clinics and sperm banks to conceive is a costly process, Doe would not be complaining if the cost of donor testing was not an issue.
Rosen said the cost of infectious disease testing, including a blood test, for a sperm donor ranges from $250 to $500 on average. He said it costs another $300 for the donor to get a physical examination from a physician to assess whether or not he's been engaged in high risk behavior that might affect his sperm.
"From a medical perspective, you don't want to infect another individual, that would be the worst scenario you could possibly imagine," said Rosen.
Like Doe and her partner, other couples seeking to conceive also opt for alternative methods to sperm banks to get pregnant.
Some enlist the help of friends to donate their sperm privately, while others consult email lists of donors passed between friends, or browse the Internet looking for answers.
Beth Gardner said that in her and her wife's pursuit to start family, they did a ton of research to help them make a decision.
While they looked into the legal ramifications of all options, there was no forum for women with similar questions to get together and share information with each other, she said.
"I thought there would be five or six websites I could read through that were like, 'How to find a private sperm donor,'" she said. "There wasn't anything but a few I had to pay for. I wasn't paying $30 a month to join a website."
So Gardner decided to start a website herself, Knowndonorregistry.com.
"We wanted to provide the resource we felt was missing, and we wanted it to be free," said Gardner.
Like Jane Doe, she and her wife had tried to get pregnant with the help of two different donors through intracervical insemination, but had no success.
The third time was a charm -- thanks to a donor they found through their website. Their daughter is now three weeks old. While the couple offered to pay for medical testing on the donor's behalf, he had recently been tested and provided them with the results.
Gardner said that while she and her wife could have afforded to pay a sperm bank, they felt the prices were exorbitant for something that was not expensive to produce.
"It pisses me off that it costs $2,000 a month just to buy sperm, it seems outlandishly expensive," she said. "Could I afford it, yes? Should I? No."
Gardner said that while her wife was more comfortable with an anonymous donor, she had problems with being prevented from knowing who the biological father of her child was.
"This is a major thing and I want to be able to talk to the person who's going to be that half of my child," she said. "I want to know that he's a decent human being or some smarmy weirdo with a desire to populate the earth with his superior genes.
"You can't get that from a profile at a sperm bank."